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Phase 2 Completed N=9 Randomized Treatment

Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer

Estrogen Receptor-negative Breast Cancer · HER2-negative Breast Cancer · Progesterone Receptor-negative Breast Cancer · Stage II Breast Cancer
Source: ClinicalTrials.gov NCT01818063 ↗
Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Jan 2018
Primary outcomePrimary: Count of Participants That Achieve Pathologic Complete Response (PCR) — 3; 3 Participants

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Count of Participants That Achieve Pathologic Complete Response (PCR)
3; 3
SECONDARY
Overall Clinical Response
1; 1; 2; 1; 2; 2
SECONDARY
Relapse Free Survival

Eligibility Criteria

Inclusion Criteria

  • Written informed consent must be obtained prior to any study-related procedures.
  • Histologically confirmed adenocarcinoma of the breast with the following markers: Estrogen receptor negative ( /= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards.
  • 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.
  • Renal function, as follows: Serum creatinine </= 1.4 mg/dL).
  • 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).
  • Patient must be willing and able to undergo MRI as outlined in protocol.

Exclusion Criteria

  • 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.
  • Known HIV or active Hepatitis B or C infection.
  • Prior treatment for the currently diagnosed breast cancer.
  • Prior treatment with doxorubicin up to 400 mg/m2.
  • Pre-existing Grade 3 or 4 sensory neuropathy.
  • History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment.
  • Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure).
  • 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.
  • Non-healing wound, ulcer or fracture.
  • Ongoing or active infection.
  • Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating
  • 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.
  • T0 tumors
  • Active dental infection
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01818063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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