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A Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

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ClinicalTrials.gov Identifier: NCT04576455
Recruitment Status : Recruiting
First Posted : October 6, 2020
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of GDC-9545 compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting.

Condition or disease Intervention/treatment Phase
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer Drug: GDC-9545 Drug: Fulvestrant or an Aromatase Inhibitor (Physician's Choice) Drug: LHRH Agonist Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Actual Study Start Date : November 27, 2020
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
Experimental: GDC-9545 Drug: GDC-9545
GDC-9545 is taken orally once per day on Days 1-28 of each 28-day cycle.
Other Names:
  • Giredestrant
  • RO7197597
  • RG6171

Drug: LHRH Agonist
Only premenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Active Comparator: Physician's Choice of Endocrine Monotherapy
The physician's choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
 Drug: Fulvestrant or an Aromatase Inhibitor (Physician's Choice)
Physician's choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.

Drug: LHRH Agonist
Only premenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months) ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization to death from any cause (up to 40 months) ]
  2. Objective Response Rate, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization until disease progression or death (up to 40 months) ]
    The objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart.

  3. Duration of Response, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 40 months) ]
  4. Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization until disease progression or death (up to 40 months) ]
    The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response (CR) or partial response (PR).

  5. Investigator-Assessed Progression-Free Survival, in Subgroups Categorized by ESR1 Mutation Status [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months) ]
  6. Time to Deterioration in Pain Severity, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the "Worst Pain" Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire [ Time Frame: From Baseline until treatment discontinuation (up to 40 months) ]
  7. Time to Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 40 months) ]
    EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30

  8. Time to Deterioration in Physical Functioning (PF), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed PF Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 40 months) ]
  9. Time to Deterioration in Role Functioning (RF), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed RF Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 40 months) ]
  10. Time to Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 40 months) ]
  11. Number of Participants with Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) [ Time Frame: From Baseline until 30 days after final dose of study drug (up to 40 months) ]
  12. Number of Participants with Vital Sign Abnormalities Over the Course of the Study [ Time Frame: Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to 40 months) ]
    Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure while the patient is in a seated position, and temperature.

  13. Number of Participants with Clinical Laboratory Test Abnormalities for Hematology Parameters Over the Course of the Study [ Time Frame: Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to 40 months) ]
  14. Number of Participants with Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study [ Time Frame: Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to 40 months) ]
  15. Plasma Concentration of GDC-9545 at Specified Timepoints [ Time Frame: Predose and postdose on Day 1 of Cycles 1 and 2, predose on Day 1 of Cycles 3, 5, 7, 9, 11, 13, and 15 (1 cycle is 28 days), and 30 days after final dose of study drug (up to 40 months) ]

Eligibility Criteria
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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:

  • For women who are premenopausal or perimenopausal or men: treatment with approved LHRH agonist therapy for the duration of study treatment
  • Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • Documented ER-positive tumor and HER2-negative tumor, assessed locally
  • Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced (recurrent or progressed) or metastatic setting
  • Measurable disease as defined per RECIST v.1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Adequate organ function

Exclusion Criteria:

  • Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant
  • Treatment with any investigational therapy within 28 days prior to randomization
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
  • Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  • Active cardiac disease or history of cardiac dysfunction
  • Pregnant or breastfeeding
Contacts and Locations
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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): NCT04576455


Contacts
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Contact: Reference Study ID Number: WO42312 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04576455    
Other Study ID Numbers: WO42312
2020-001984-10 ( EudraCT Number )
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action