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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2024
• Main ID: NCT02163694
• Date of registration: 19/05/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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
• Scientific 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
• Date of first enrolment: July 17, 2014
• Target sample size: 509
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02163694
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Czech Republic, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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 Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer
Gene 2 (BRCA2) germline mutation.

3. Breast cancer must be Human Epidermal Growth Factor Receptor 2 (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. Eastern Cooperative Oncology Group (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,
neoadjuvant, or metastatic).

3. Prior therapy with Poly(ADP-ribose)-Polymerase (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
Cycle 1 Day-2 (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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: Veliparib

Drug: Veliparib Placebo

Drug: Carboplatin

Drug: Paclitaxel

Primary Outcome(s)

Progression-Free Survival (PFS) [Time Frame: From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months]

Secondary Outcome(s)

Objective Response Rate (ORR) [Time Frame: Approximately 8 years from randomization]

Clinical Benefit Rate (CBR) [Time Frame: Through the end of Week 24]

Overall Survival (OS) [Time Frame: Approximately 8 years from randomization]

Progression-Free Survival on Subsequent Therapy (PFS2) [Time Frame: Approximately 8 years from randomization]

Secondary ID(s)

2014-000345-70

M12-914

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02163694