A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic or Locally Advanced Unresectable Breast Cancer Gene (BRCA)-Associated Breast Cancer

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic or Locally Advanced Unresectable Breast Cancer Gene (BRCA)-Associated Breast Cancer

Description

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.

Details
Condition Breast Cancer
Clinical Study IdentifierTX141317
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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
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 or neoadjuvant)
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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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