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
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02163694 |
Recruitment Status :
Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : August 21, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Drug: Paclitaxel Drug: Veliparib Drug: Carboplatin Drug: Veliparib Placebo | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
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 |
Actual Primary Completion Date : | April 5, 2019 |
Estimated Study Completion Date : | November 13, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Veliparib Placebo with Carboplatin and Paclitaxel
Veliparib Placebo on Day -2 through 5 of a 21-day cycle. Carboplatin on Day 1 of a 21-day cycle and paclitaxel on Day 1, 8, and 15 of a 21-day cycle.
|
Drug: Paclitaxel
Intravenous (IV) Infusion
Other Name: Taxol Drug: Carboplatin Intravenous (IV) Infusion Drug: Veliparib Placebo Capsule; Oral |
Experimental: Veliparib with Carboplatin and Paclitaxel
Veliparib on Day -2 through 5 of a 21-day cycle. Carboplatin on Day 1 of a 21-day cycle and paclitaxel on Day 1, 8, and 15 of a 21-day cycle.
|
Drug: Paclitaxel
Intravenous (IV) Infusion
Other Name: Taxol Drug: Veliparib Capsule; Oral
Other Name: ABT-888 Drug: Carboplatin Intravenous (IV) Infusion |
- Progression free survival (PFS) [ Time Frame: Measured up to 3 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
- 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
- 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
- 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
- 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

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation.
- Breast cancer must be HER2-negative.
- 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.
- Eastern Cooperative Oncology group (ECOG) Performance status of 0 to 2.
- Adequate hematologic, renal, and hepatic function (within 28 days of randomization).
Exclusion Criteria:
-
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.
- 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, neoadjuvant, or metastatic).
- Prior therapy with PARP inhibitors.
-
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
- 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.
- Active CNS metastases or leptomeningeal disease.

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

Study Director: | AbbVie Inc. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02163694 |
Other Study ID Numbers: |
M12-914 2014-000345-70 ( EudraCT Number ) |
First Posted: | June 16, 2014 Key Record Dates |
Last Update Posted: | August 21, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. |
URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
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 |
PARP Inhibitor Veliparib BRCA1 BRCA2 HER2-negative Locally recurrent Breast Cancer Metastatic Breast Cancer |
ABT-888 Genetic breast cancer Paclitaxel BRCA Mutation PARP Carboplatin BROCADE3 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Carboplatin Veliparib |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors |