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A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

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ClinicalTrials.gov Identifier: NCT02163694
Recruitment Status : Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Paclitaxel Drug: Veliparib Drug: Carboplatin Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
Actual Study Start Date : August 5, 2014
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo with Carboplatin and Paclitaxel
Placebo on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.
Drug: Paclitaxel
Day 1 of 21-day cycle
Other Name: Taxol

Drug: Carboplatin
Day 1 of 21-day cycle

Other: Placebo
Placebo on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.

Experimental: Veliparib with Carboplatin and Paclitaxel
Veliparib on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.
Drug: Paclitaxel
Day 1 of 21-day cycle
Other Name: Taxol

Drug: Veliparib
Veliparib on Day -2 through 5 of a 21-day cycle. In addition, carboplatin and paclitaxel will be administered on Day 1 of a 21-day cycle.
Other Name: ABT-888

Drug: Carboplatin
Day 1 of 21-day cycle




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Number of days from the date the subject is randomized to the date the subject experiences a confirmed event of disease progression or to the date of death if disease progression is not reached


Secondary Outcome Measures :
  1. Duration of overall response (DOR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    Number of days from the day the criteria are met for complete response or partial response (whichever is recorded first) to the date of progressive disease

  2. Progression-free survival 2 (PFS2) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Days from randomization to the second objective radiographic progression or death of any cause after the first objective radiographic progression, whichever occurs first

  3. Objective response rate (ORR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    Proportion of subjects with a complete or partial objective response

  4. Overall survival (OS) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Number of days from the day the subject is randomized to the date of the subject's death

  5. Clinical benefit rate (CBR) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Progression-free rate at 24 weeks from the Kaplan-Meier curve for time to progression


Other Outcome Measures:
  1. Change in quality of life (QOL) [ Time Frame: Measured up to 5 years after the last subject has enrolled in the study. ]
    Assessed via survey

  2. Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    Change in ECOG performance status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic. Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent.
  2. Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation.
  3. Breast cancer must be HER2-negative.
  4. Measurable or non-measurable (but radiologically evaluable) disease per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT) scan (within 28 days of randomization) with at least one lesion outside previously irradiated areas.
  5. ECOG Performance status of 0 to 2.
  6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).

Exclusion Criteria:

  1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease.

    • Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months.
    • Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy.
  2. Progressed or recurred within 12 months of completing platinum therapy or received > 1 prior line of platinum therapy for breast cancer in any setting (adjuvant or neoadjuvant).
  3. Prior therapy with PARP inhibitors.
  4. Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.

    • Prior taxane therapy for metastatic breast cancer is allowed if the patient received ≤ 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of progression or if taxane therapy for metastatic disease was > 12 months prior to C1D-2.
    • Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2
  5. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.
  6. Active CNS metastases or leptomeningeal disease.

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): NCT02163694


  Show 196 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02163694     History of Changes
Other Study ID Numbers: M12-914
2014-000345-70 ( EudraCT Number )
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
PARP Inhibitor
Veliparib
BRCA1
BRCA2
HER2-negative
Locally recurrent
Breast Cancer
Metastatic Breast Cancer
ABT-888
Genetic breast cancer
Paclitaxel
BRCA Mutation
PARP
Carboplatin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Veliparib
Albumin-Bound Paclitaxel
Carboplatin
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors