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

Breast Cancer Clinical Trial

Official title:

Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232479
• Other study ID #: SCCC 2004-064
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2005
• Last updated: July 16, 2012
• Start date: September 2005
• Est. completion date: June 2008

Study information

• Verified date: July 2012
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HER-2 overexpressing breast cancer

• Clinical stage 2-3B

• Normal ejection fraction

Exclusion Criteria:

• Metastatic disease

• Low ejection fraction

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• trastuzumab, docetaxel and carboplatin in dose dense regimen
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

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and Tolerability	the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability	from the first dose of chemotherapy until surgery which was approximately 16 weeks.	Yes