Clinical trial · Interventional
Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced Breast Cancer
A Phase I-II Study of R115777 (ZARNESTRA) Plus Doxorubicin and Cyclophosphamide in Patients With Locally Advanced Breast Cancer and Metastatic Breast Cancer
NCT00049114CI-TRIAL-00010641completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with doxorubicin and cyclophosphamide may kill more tumor cells. Phase II trial to study the effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women who have locally advanced breast cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Breast Cancer | Breast Inflammatory Carcinoma | ALIAS | 0.90 |
| 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 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (doxorubicin, cyclophosphamide, tipifarnib, G-CSF)
- description
- PHASE I (nonregional stage IV disease) (closed to accrual as of 1/19/04): Patients receive doxorubicin IV over 10-15 minutes and cyclophosphamide IV over 30 minutes on day 1, oral tipifarnib twice daily on days 2-7, and G-CSF subcutaneously on days 2-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. PHASE II (stage IIB, IIIA, IIIB, or IIIC): Patients receive tipifarnib at the MTD and doxorubicin, cyclophosphamide, and G-CSF as in phase I (phase I closed to accrual as of 1/19/04). After the fourth course, patients may undergo complete resection.
- interventionNames
- Drug: doxorubicin hydrochloride
- Drug: cyclophosphamide
- Drug: tipifarnib
- Biological: filgrastim
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Pathological complete response in the breast
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the breast
* Phase I (closed to accrual as of 1/19/04):
* Nonregional stage IV disease
* Phase II:
* Locally advanced disease, according to AJCC staging criteria:
* Stage IIB
* Stage IIIA
* Stage IIIB
* Stage IIIC
* At least 1 bidimensionally or unidimensionally measurable indicator lesion
* Hormone receptor status:
* Not specified
* Female
* Performance status - ECOG 0-1
* Performance status - Karnofsky 70-100%
* Not specified
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* LVEF normal
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No other invasive malignancies within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No prior allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib or other agents used in the study (e.g., imidazoles or quinolones)
* No ongoing or active infection
* No other concurrent uncontrolled illness that would preclude study participation
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not specified
* Phase I (closed to accrual as of 1/19/04):
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No more than 1 prior adjuvant/neoadjuvant regimen and 1 prior regimen for metastatic disease
* Prior doxorubicin allowed provided the following are true:
* Used in adjuvant setting
* Cumulative dose was no greater than 240 mg/m\^2
* At least 1 year between completion of adjuvant therapy and relapse
* Phase II:
* No prior chemotherapy for locally advanced breast cancer
* At least 1 week since prior tamoxifen or other selective estrogen receptor modulators for prevention or other indications (e.g., osteoporosis, ductal carcinoma in situ, or invasive breast cancer)
* Phase I (closed to accrual as of 1/19/04):
* More than 4 weeks since prior radiotherapy
* Phase II:
* No prior radiotherapy for locally advanced breast cancer
* Not specified
* No antacids within 2 hours of study drug administration
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy
* No other concurrent investigational agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.