Phase 2
Completed N=60
Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer
Breast Cancer · male breast cancer · Stage II Breast Cancer · Stage IIIA Breast Cancer
Source: ClinicalTrials.gov NCT00470301 ↗
Enrolled (actual)
60
Serious AEs
21.7%
Results posted
May 2015
Primary outcomePrimary: Pathologic Complete Response Rate (pCR) — 33 participants
Summary
Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with combination chemotherapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy and to see how well they work in treating patients with stage II or stage III breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response Rate (pCR) |
33 | — |
| PRIMARY Number of Participants Analyzed for Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast; clinical stage IIB, IIIA, IIIB, or IIIC disease
- At least 1 week since prior tamoxifen or other selective estrogen receptor modulator for prevention or for other indications (e.g., osteoporosis or prior ductal carcinoma in situ)
- HER-2/neu-negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
- Hormone receptor status:
- Estrogen and/or progesterone receptor-positive* [Note: *Patients enrolled on the phase I portion of the trial may have estrogen and progesterone receptor-negative disease]
- Normal organ function including:
- WBC >= 3,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Bilirubin normal
- AST and ALT = = 60 mL/min
- FEV1 >= 1 L* and DLCO >= 50%* [Note: *Only if baseline CT scan of chest shows parenchymal lung disease OR there is a history of chronic obstructive or other pulmonary disease]
- No prior chemotherapy, radiotherapy, or definitive therapeutic surgery (e.g., mastectomy, lumpectomy, or axillary dissection) for this cancer but prior sentinel lymph node biopsy for this malignancy allowed
- No prior adjuvant chemotherapy for a previous breast malignancy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- ECOG performance status 0-1
- Fertile patients must use effective contraception
Exclusion criteria
- No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib or other study drugs (e.g., imidazoles or quinolones)
- No other uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would preclude study compliance
- Not pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT00470301). 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.