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A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05374512
Recruitment Status : Recruiting
First Posted : May 16, 2022
Last Update Posted : September 29, 2022
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Dato-DXd Drug: Paclitaxel Drug: Nab-paclitaxel Drug: Carboplatin Drug: Capecitabine Drug: Eribulin mesylate Phase 3

Detailed Description:
The primary objectives of the study are to demonstrate superiority of Dato-DXd relative to ICC by assessment of PFS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, per BICR and to demonstrate superiority of Dato-DXd relative to ICC by assessment of OS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)
Actual Study Start Date : May 16, 2022
Estimated Primary Completion Date : December 3, 2025
Estimated Study Completion Date : December 3, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Dato-DXd
Arm 1: Dato-DXd
Drug: Dato-DXd
Experimental drug. Provided in 100mg vials. IV infusion.
Other Name: Datopotamab deruxtecan (Dato-DXd, DS-1062a)

Active Comparator: Investigator's Choice of Chemotherapy (ICC)

Arm 2:

If no prior taxane, or prior taxane in the (neo)adjuvant setting and DFI > 12 months, paclitaxel or nab-paclitaxel

If prior taxane and DFI ≤ 12 months: capecitabine, carboplatin, or eribulin.

Drug: Paclitaxel
IV Infusion. Active comparator

Drug: Nab-paclitaxel
IV infusion. Active comparator

Drug: Carboplatin
IV infusion. Active comparator

Drug: Capecitabine
Tablet. Oral route of administration. Active comparator

Drug: Eribulin mesylate
IV infusion. Active comparator




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From randomization until progression as assessed by BICR or death due to any cause (anticipated to be up to 26 months) ]

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.

    The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at the time of the latest evaluable assessment prior to the 2 missed visits.

    The measure of interest is the hazard ratio [HR] of PFS.


  2. Overall Survival (OS) [ Time Frame: From randomisation until the date of death due to any cause (approximately 42 months) ]

    OS is defined as the time from randomisation until the date of death due to any cause.

    The analysis will include all randomised participants, by treatment group as randomised. The measure of interest is the hazard ratio [HR] of OS.



Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From randomisation up until progression (anticipated to be up to 26 months) ]

    ORR is defined as the proportion of participants who have a confirmed CR or PR, as determined by BICR/investigator assessment, per RECIST 1.1.

    The analysis will include all randomised participants, by treatment group as randomised.

    Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR, regardless of whether the participant withdraws from therapy. Participants who go off treatment without a response or progression, receive a subsequent anti-cancer therapy, and then respond will not be included as responders in the ORR.

    The measure of interest is the odds ratio of the ORR.


  2. Duration of Response (DoR) [ Time Frame: From the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause (anticipated to be up to 26 months) ]

    DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause.

    The analysis will include all randomised participants as randomised who have a confirmed response, regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.

    The measure of interest is the median of DoR,


  3. Progression-Free Survival (PFS) by Investigator assessment [ Time Frame: From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 26 months) ]

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause.

    The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.

    The measure of interest is the hazard ratio [HR] of PFS.


  4. Time to deterioration (TTD) in pain in participants treated with Dato DXd compared with ICC [ Time Frame: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression) ]

    TTD in pain as measured by the pain scale from EORTC IL146. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in pain.


  5. Time to deterioration (TTD) in physical functioning in participants treated with Dato DXd compared with ICC [ Time Frame: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression) ]

    TTD in physical functioning as measured by the physical functioning scale from EORTC IL146.

    TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in physical functioning.


  6. Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato DXd compared to ICC [ Time Frame: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression) ]
    • TTD in breast symptoms as measured by the breast symptoms scale from EORTC IL116
    • TTD in arm symptoms as measured by the arm symptoms scale from EORTC IL116 TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in breast symptoms/arm symptoms.


  7. Time to deterioration (TTD) in GHS/QoL in participants treated with Dato DXd compared with ICC [ Time Frame: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression) ]

    TTD in GHS/QoL as measured by the GHS/QoL scale from EORTC IL146. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in GHS/QoL.


  8. Time to First Subsequent Therapy (TFST) [ Time Frame: From randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause (anticipated to be up to 26 months) ]

    TFST is defined as the time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.

    The analysis will include all randomised participants as randomised, regardless of progression status.

    The measure of interest is the hazard ratio [HR] of TFST.


  9. Time to Second Subsequent Therapy (TSST) [ Time Frame: From randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (anticipated to be up to 26 months) ]

    TSST is defined as the time from randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

    The analysis will include all randomised participants as randomised, regardless of progression status on study treatment or first subsequent treatment.

    The measure of interest is the hazard ratio [HR] of TSST.


  10. Progression Free Survival 2 (PFS2) [ Time Frame: From randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death (anticipated to be up to 26 months) ]

    PFS2 will be defined as the time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.

    The analysis will include all randomised participants as randomised regardless of whether the participant withdraws from subsequent therapy and regardless of missed visits.

    The measure of interest is the hazard ratio [HR] of PFS2.


  11. Pharmacokinetics of Dato-DXd [ Time Frame: From first dose to end of treatment (anticipated to be up to 26 months) ]
    Concentration of Dato DXd, total anti-TROP2 antibody, and MAAA-1181a in plasma.

  12. Immunogenicity of Dato-DXd [ Time Frame: From first dose to end of treatment safety follow-up (anticipated to be up to 26 months) ]
    Presence of ADAs for Dato-DXd (confirmatory results: positive or negative, titres).

  13. Safety of Dato-DXd [ Time Frame: From first dose to end of treatment safety follow-up (anticipated to be up to 26 months) ]
    Safety will be evaluated in terms of AEs (graded by CTCAE version 5.0)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age

  1. Participant must be ≥ 18 years (≥ 20 years in Japan) at the time of screening. Type of Participant and Disease Characteristics
  2. Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC. TNBC is defined as:

    • Negative for ER with < 1% of tumour cells positive for ER on IHC.
    • Negative for progesterone receptor with < 1% of tumour cells positive for progesterone receptor on IHC.
    • Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridisation per the ASCO-CAP HER2 guideline
  3. No prior chemotherapy or targeted systemic therapy for metastatic or locally recurrent inoperable breast cancer.
  4. Not a candidate for PD-1/PD-L1 inhibitor therapy, defined as:

    • Participants whose tumours are PD-L1-negative, or
    • Participants whose tumours are PD-L1-positive and have:

      1. relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer,
      2. comorbidities precluding PD-1/PD-L1 inhibitor therapy, or
      3. no regulatory access to pembrolizumab [participant's country does not have regulatory approval at the time of screening]).
  5. At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), and is suitable for accurate repeated measurements.
  6. ECOG PS 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
  7. Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, capecitabine, carboplatin, or eribulin), per investigator assessment.
  8. Has had an adequate treatment washout period before Cycle 1 Day 1, defined as:

    • Major surgery: ≥ 3 weeks.
    • Radiation therapy including palliative radiation to chest: ≥ 4 weeks (palliative radiation therapy to other areas ≥ 2 weeks).
    • Corticosteroid therapy for central nervous system metastatic disease: > 3 days.
    • Anti cancer therapy including hormonal therapy: ≥ 3 weeks (for small molecule targeted agents: ≥ 2 weeks or 5 half-lives, whichever is longer).
    • Antibody-based anti cancer therapy: ≥ 4 weeks with the exception of receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors (eg, denosumab for the treatment of bone metastases).
    • Chloroquine/hydroxychloroquine: > 14 days.
  9. Written confirmation of tumour sample needs to be available prior to enrolment and tumour samples should be available prior to randomisation. All participants must have a FFPE metastatic (excluding bone) or locally recurrent inoperable tumour sample (block preferred, or a minimum of 20 freshly cut slides) available, collected ≤ 3 months prior to screening. If neither an adequate FFPE block nor the minimum of 20 slides are available from the most recent biopsy, or if a biopsy is not feasible for safety reasons, and this is clearly documented, an archival tumour specimen obtained before the diagnosis of locally recurrent inoperable or metastatic breast cancer may be submitted, pending approval by the Global Study Team.
  10. Participants with a history of previously treated neoplastic spinal cord compression or clinically inactive brain metastases, who require no treatment with corticosteroids or anticonvulsants may be included in the study, if they have recovered from acute toxic effects of radiotherapy. A minimum of 2 weeks must have elapsed between the end of radiotherapy and study enrolment. A minimum of 3 days must have elapsed between the end of corticosteroid therapy for central nervous system metastatic disease and study enrolment.
  11. Adequate organ and bone marrow function within 7 days before day of first dosing as follows:

    • Haemoglobin ≥ 9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).
    • Absolute neutrophil count ≥ 1.5 × 10^9/L (granulocyte colony stimulating factor administration is not allowed within 1 week prior to screening assessment).
    • Platelet count ≥ 100 × 10^9/L (platelet transfusion is not allowed within 1 week prior to screening assessment).
    • Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or < 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN for AST/ALT (< 5 × ULN in participants with liver metastases).
    • Calculated CrCL ≥ 30 mL/minute as determined by Cockcroft Gault
    • International normalised ratio (INR) or prothrombin time, and either partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN.
  12. Minimum life expectancy of 12 weeks.

    Sex

  13. Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    Reproduction

  14. Negative pregnancy test (serum) for women of childbearing potential.
  15. Female participants must be at least 1 year post-menopausal, surgically sterile, or using at least 1 highly effective form of birth control (a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) Women of childbearing potential who are sexually active with a non sterilised male partner must agree to use at least 1 highly effective method of birth control. They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and continue for at least 7 months after the last dose. Female participants must refrain from egg cell donation and breastfeeding while on study and for at least 7 months after the last dose of study drug. Any non sterilised male partner of a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period.
  16. Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or use an acceptable method of contraception from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and drug washout period is an acceptable practice, if this is the preferred usual lifestyle of the participant. Periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

    Informed Consent

  17. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  18. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of sample for optional genetic research that supports Genomic Initiative.

Exclusion Criteria:

Medical Conditions

  1. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, uncontrolled hypertension, history of allogeneic organ transplant, and active bleeding diseases, ongoing or active infection, or significant cardiac or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
  2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence (per investigator assessment). Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that have undergone potentially curative therapy, adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumours curatively treated.
  3. Persistent toxicities caused by previous anti cancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss) after consultation with the sponsor study clinical lead or designee. Note: per the discretion of the investigator after consultation with the sponsor study clinical lead or designee, participants may be enrolled with some chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to first dosing and managed with SoC treatment) which the investigator deems related to previous anti cancer therapy.
  4. Uncontrolled infection requiring IV antibiotics, antivirals or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localised fungal infections of skin or nails are eligible).
  5. Known active or uncontrolled hepatitis B or C virus infection; or is positive for hepatitis B or C virus, based on the evaluation of tests for hepatitis B (hepatitis B virus surface antigen, anti-hepatitis B virus surface antibody, and anti hepatitis B virus core antibody, or hepatitis B virus DNA) or hepatitis C (hepatitis C antibody or hepatitis C virus ribonucleic acid [RNA]) infection at screening. Participants who have received hepatitis B vaccination with only anti-hepatitis B virus surface antibody positivity and no clinical signs of hepatitis, and participants who have been curatively treated for hepatitis C infection (as demonstrated clinically and by viral serologies) are eligible.
  6. Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load, cluster of differentiation (CD)4+ count > 250 cells/mm3, no history of an acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications.
  7. Uncontrolled or significant cardiac disease including:

    • Myocardial infarction or uncontrolled/unstable angina within 6 months prior to Cycle 1 Day 1
    • Congestive heart failure (New York Heart Association Class II to IV), or
    • Uncontrolled or significant cardiac arrhythmia, or
    • Uncontrolled hypertension (resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
  8. Investigator judgment of any one of the following:

    • Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) > 470 ms regardless of gender, obtained from triplicate 12-lead electrocardiograms (ECGs) performed at screening.
    • History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and/or cause Torsades de Pointes.
    • Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
  9. Uncontrolled hypercalcaemia: > 1.5 mmol/L (> 6 mg/dL) ionised calcium, or serum calcium (uncorrected for albumin) > 3 mmol/L (> 12 mg/dL), or corrected serum calcium > ULN, or clinically significant (symptomatic) hypercalcaemia.
  10. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  11. Clinically severe pulmonary function compromise resulting from intercurrent clinically significant pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of first dosing, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) where there is documented or suspected pulmonary involvement at the time of screening.
  12. Leptomeningeal carcinomatosis.
  13. Clinically significant corneal disease.
  14. Known active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).

    Prior/Concomitant Therapy

  15. Prior exposure to:

    • Any treatment (including ADC) containing a chemotherapeutic agent targeting topoisomerase I
    • TROP2-targeted therapy
    • Prior treatment with same ICC agent
    • Chloroquine/hydroxychloroquine without an adequate treatment washout period of > 14 days prior to randomisation.
  16. Any concurrent anti cancer treatment.
  17. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy [HRT], except topical).
  18. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
  19. Receipt of live, attenuated vaccine within 30 days prior to the first dose of study treatment.
  20. Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intra articular steroid injections are permitted in this study).

    Prior/Concurrent Clinical Study Experience

  21. Previous treatment in the present study.
  22. Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention, randomisation into a prior T-DXd or Dato DXd study regardless of treatment assignment, or concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study.
  23. Participants with a known severe hypersensitivity to Dato DXd or any of the excipients of the product, including but not limited to polysorbate 80.
  24. Known history of severe hypersensitivity reactions to other monoclonal antibodies.

    Other Exclusions

  25. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  26. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
  27. Currently pregnant (confirmed with positive pregnancy test) or breast feeding or planning to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05374512


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
Daiichi Sankyo, Inc.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05374512    
Other Study ID Numbers: D926PC00001
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Breast Cancer;
PD-1/PD-L1 Therapy;
Dato-DXd; DS1062a;
TROP2;
Triple-negative;
Metastatic; Inoperable;
Datopotamab deruxtecan;
Antibody Drug Conjugate;
ADC
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites