Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer

NCT00232479 | Completed Phase 2 Results DMC

• 1 other identifier: SCCC 2004-064
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Pathologic Complete Response (pCR)

  pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.

  determined at the time of surgery which is approximately 16 weeks from the beginning of treatment

Secondary Outcomes (1)

• Safety and Tolerability

  from the first dose of chemotherapy until surgery which was approximately 16 weeks.

Study Arms (1)

arm 1

EXPERIMENTAL

single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion

Drug: trastuzumab, docetaxel and carboplatin in dose dense regimen

Interventions

trastuzumab, docetaxel and carboplatin in dose dense regimen DRUG

trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44

Also known as: herceptin, taxotere and carboplatin

arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HER-2 overexpressing breast cancer
• Clinical stage 2-3B
• Normal ejection fraction

You may not qualify if:

• Metastatic disease
• Low ejection fraction

Sponsors & Collaborators

• University of Miami: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Judith Hurley
• Organization: UMiami

jhurley@miami.edu

305-243-6698

Study Officials

• Judith Hurley

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: September 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 21, 2012
• Results First Posted: August 21, 2012

Record last verified: 2012-07

Locations

US (1)