Trial Outcomes & Findings for Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer (NCT NCT00470301)

Results Overview

An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2021-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I See Detailed Description tipifarnib: Given orally paclitaxel: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV pegfilgrastim: Given SC conventional surgery: surgical procedures performed on patients axillary lymph node dissection: correlative study
Overall Study STARTED	60
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=60 Participants See Detailed Description tipifarnib: Given orally paclitaxel: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV pegfilgrastim: Given SC conventional surgery: surgical procedures performed on patients axillary lymph node dissection: correlative study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.

Outcome measures

Outcome measures
Measure	Arm I n=55 Participants See Detailed Description tipifarnib: Given orally paclitaxel: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV pegfilgrastim: Given SC conventional surgery: surgical procedures performed on patients axillary lymph node dissection: correlative study
Pathologic Complete Response Rate (pCR)	33 participants Interval 7.0 to 36.0

PRIMARY outcome

Timeframe: 1 year

Population: Total participants analyzed is 6. 3 received 100 mg PO BID tipifarnib and 3 received 200 mg PO BID tipifarnib.

The recommended phase II dose of tipifarnib (100 or 200 mg PO BID on days 1-3 each paclitaxel dose) in combination with paclitaxel (80 mg/m2/week x 12 consecutive weeks)

Outcome measures

Outcome measures
Measure	Arm I n=6 Participants See Detailed Description tipifarnib: Given orally paclitaxel: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV pegfilgrastim: Given SC conventional surgery: surgical procedures performed on patients axillary lymph node dissection: correlative study
Number of Participants Analyzed for Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I) Number of participants with DLT (100 mg PO BID tipifarnib)	0 participants
Number of Participants Analyzed for Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I) Number of participants with DLT (200 mg PO BID tifiparnib)	0 participants

Adverse Events

Arm I

Serious events: 13 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=60 participants at risk See Detailed Description tipifarnib: Given orally paclitaxel: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV pegfilgrastim: Given SC conventional surgery: surgical procedures performed on patients axillary lymph node dissection: correlative study
Blood and lymphatic system disorders Neutropenia	21.7% 13/60

Other adverse events

Other adverse events
Measure	Arm I n=60 participants at risk See Detailed Description tipifarnib: Given orally paclitaxel: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV pegfilgrastim: Given SC conventional surgery: surgical procedures performed on patients axillary lymph node dissection: correlative study
General disorders Fatigue	46.7% 28/60

Additional Information

NYCC Coordinating Center

Montefiore Medical Center

Phone: 718-405-8404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60