NCT00470301

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 22, 2015

Completed
Last Updated

February 16, 2021

Status Verified

January 1, 2021

Enrollment Period

6.4 years

First QC Date

May 3, 2007

Results QC Date

May 6, 2015

Last Update Submit

January 29, 2021

Conditions

Breast CancerMale Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Pathologic Complete Response Rate (pCR)

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

    Up to 5 years

  • Number of Participants Analyzed for Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I)

    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)

    1 year

Study Arms (1)

Arm I

EXPERIMENTAL

Tipifarnib plus sequential weekly paclitaxel followed by doxorubicin plus cyclophosphamide

Drug: tipifarnibDrug: paclitaxelDrug: doxorubicinDrug: cyclophosphamide

Interventions

tipifarnibDRUG

Given orally

Also known as: R115777, Zarnestra
Arm I
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Arm I
doxorubicinDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Arm I
cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 =\< 2.5 times upper limit of normal
  • LVEF normal by echocardiogram or nuclear scan
  • Creatinine normal OR Creatinine clearance \>= 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Andreopoulou E, Vigoda IS, Valero V, Hershman DL, Raptis G, Vahdat LT, Han HS, Wright JJ, Pellegrino CM, Cristofanilli M, Alvarez RH, Fehn K, Fineberg S, Sparano JA. Phase I-II study of the farnesyl transferase inhibitor tipifarnib plus sequential weekly paclitaxel and doxorubicin-cyclophosphamide in HER2/neu-negative inflammatory carcinoma and non-inflammatory estrogen receptor-positive breast carcinoma. Breast Cancer Res Treat. 2013 Oct;141(3):429-35. doi: 10.1007/s10549-013-2704-x. Epub 2013 Sep 26.

    PMID: 24068539RESULT

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

tipifarnibPaclitaxelTaxesDoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
NYCC Coordinating Center
Organization
Montefiore Medical Center
jsparano@montefiore.org
718-405-8404

Study Officials

  • Dawn Hershman

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 16, 2021

Results First Posted

May 22, 2015

Record last verified: 2021-01

Locations

US(7)