ClinicalTrials.Veeva

Menu

A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

AbbVie logo

AbbVie

Status and phase

Completed
Phase 3

Conditions

Triple Negative Breast Cancer

Treatments

Drug: Carboplatin
Drug: Paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Placebo
Drug: Veliparib

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT02032277
2013-002377-21 (EudraCT Number)
M14-011

Details and patient eligibility

About

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

Enrollment

634 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
  2. Documented Breast Cancer Gene (BRCA) germline mutation testing.
  3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
  4. ECOG Performance status of 0 to 1.
  5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

Exclusion criteria

  1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
  2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
  3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
  4. A history of seizure within 12 months prior to study entry.
  5. Pre-existing neuropathy from any cause in excess of Grade 1.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

634 participants in 3 patient groups, including a placebo group

Arm A
Active Comparator group
Description:
Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
Treatment:
Drug: Veliparib
Drug: Carboplatin
Drug: Paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Arm C
Placebo Comparator group
Description:
Placebo + placebo + paclitaxel followed by AC.
Treatment:
Drug: Placebo
Drug: Paclitaxel
Drug: Placebo
Drug: Doxorubicin
Drug: Cyclophosphamide
Arm B
Placebo Comparator group
Description:
Placebo + carboplatin + paclitaxel followed by AC
Treatment:
Drug: Placebo
Drug: Carboplatin
Drug: Paclitaxel
Drug: Placebo
Drug: Doxorubicin
Drug: Cyclophosphamide

Trial contacts and locations

158

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems