Clinical trial · Interventional
Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer
An Adaptive, Randomized Phase II Trial to Determine Pathologic Complete Response With the Addition of Carboplatin With and Without Veliparib to Standard Chemotherapy in the Neoadjuvant Treatment of Triple-Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial studies how well carboplatin and combination chemotherapy with or without veliparib works in treating patients with stage IIB-IIIC breast cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and combination chemotherapy are more effective with or without veliparib is more effective in treating breast cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Progesterone Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Veliparib | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 (paclitaxel, carboplatin)
- description
- Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Arm 2 (veliparib, paclitaxel, carboplatin)
- description
- Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent must be obtained prior to any study-related procedures. 2. Histologically confirmed adenocarcinoma of the breast with the following markers: Estrogen receptor negative (\<1%), progesterone receptor negative (\<1%), and Her-2/neu negative (Her-2/neu 0-1+ IHC or FISH ratio \<1.8 or average HER2 gene copy number of \<four signal/nucleus for test systems without internal control probe). 3. Female ≥ 18 years old. 4. Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment. 5. Complete radiology or tumor assessment within 28 days prior to enrollment 1. Breast MRI 2. Unilateral Breast Ultrasound 3. Distant metastatic work-up completed with PET/CT. 4. If enlarged axillary lymph nodes are found during staging scans, FNA must be performed to determine whether the node is involved with cancer. 5. If axillary lymph nodes are clinically negative during initial work-up, sentinel node biopsy will be performed prior to initiation of chemotherapy. 6. ECOG Performance Status of 0 or 1 7. Adequate organ and hematologic function as evidenced by the following laboratory studies within 4 weeks of study enrollment: 1. Cardiac Ejection Fraction \>/= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards. 2. Hematologic function, as follows: Absolute neutrophil count ≥ 1.5 x 109/L, Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L, Hemoglobin ≥ 9 g/dL, PTT and INR \< 1.5 x ULN. 3. Renal function, as follows: Serum creatinine \</= 1.4 mg/dL). 4. Hepatic function, as follows:Aspartate aminotransferase (AST) ≤ 2.5 x ULN, Alanine aminotransferase (ALT) ≤ 2.5 x ULN , Total bilirubin ≤ 2 x ULN (except for patients with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to study enrollment. Patients enrolled with Gilbert syndrome must have total bilirubin \< 3 ULN). 8. Patient must be willing and able to undergo MRI as outlined in protocol. Exclusion Criteria: 1. Known hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, cremophor or medications containing cremophor(miconazole, docetaxel, sandimmune, nelfinavir mesylate, propofol, diazepam injection, vitamin K injection, ixabepilone, aci-jel) or carboplatin. 2. Known HIV or active Hepatitis B or C infection. 3. Prior treatment for the currently diagnosed breast cancer. 4. Prior treatment with doxorubicin up to 400 mg/m2. 5. Pre-existing Grade 3 or 4 sensory neuropathy. 6. History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment. 7. Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure). 8. Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker. 9. Non-healing wound, ulcer or fracture. 10. Ongoing or active infection. 11. Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating 12. Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence. Contraception must be used during the study. 13. T0 tumors 14. Active dental infection
References
Publications (41)
- BACKGROUNDPerou CM. Molecular stratification of triple-negative breast cancers. Oncologist. 2011;16 Suppl 1:61-70. doi: 10.1634/theoncologist.2011-S1-61. PMID 21278442
- BACKGROUNDDent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, Lickley LA, Rawlinson E, Sun P, Narod SA. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34. doi: 10.1158/1078-0432.CCR-06-3045. PMID 17671126
- BACKGROUNDBauer KR, Brown M, Cress RD, Parise CA, Caggiano V. Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer Registry. Cancer. 2007 May 1;109(9):1721-8. doi: 10.1002/cncr.22618. PMID 17387718
- BACKGROUNDLund MJ, Butler EN, Bumpers HL, Okoli J, Rizzo M, Hatchett N, Green VL, Brawley OW, Oprea-Ilies GM, Gabram SG. High prevalence of triple-negative tumors in an urban cancer center. Cancer. 2008 Aug 1;113(3):608-15. doi: 10.1002/cncr.23569. PMID 18484596
- BACKGROUNDBosch A, Eroles P, Zaragoza R, Vina JR, Lluch A. Triple-negative breast cancer: molecular features, pathogenesis, treatment and current lines of research. Cancer Treat Rev. 2010 May;36(3):206-15. doi: 10.1016/j.ctrv.2009.12.002. Epub 2010 Jan 8. PMID 20060649
- BACKGROUNDNCCN. NCCN Clinical Practice Guidelines in Oncology, Version 2.2011. 2011.
- BACKGROUNDHenderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential Paclitaxel but not from escalating Doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. doi: 10.1200/JCO.2003.02.063.