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Trial record 1 of 1 for:    NCT02163694
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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

This study is currently recruiting participants.
Verified November 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02163694
First Posted: June 16, 2014
Last Update Posted: November 10, 2017
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.
Information provided by (Responsible Party):
AbbVie
May 19, 2014
June 16, 2014
November 10, 2017
July 30, 2014
May 31, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02163694 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Same as current
  • 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
  • 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
Same as current
 
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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • 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
  • Drug: Paclitaxel
    Day 1 of 21-day cycle
    Other Name: Taxol
  • 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.
    Interventions:
    • Drug: Veliparib
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • 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.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
May 30, 2019
May 31, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact: Abbvie Emerging Med 844-893-5525 AbbVie@emergingmed.com
Argentina,   Australia,   Austria,   Belarus,   Belgium,   Canada,   Chile,   Colombia,   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
Czech Republic
 
NCT02163694
M12-914
2014-000345-70 ( EudraCT Number )
Yes
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: David Maag, PhD AbbVie
AbbVie
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP