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NCT Number: NCT00232479

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Metastatic disease
  • Low ejection fraction

Treatment and study plan

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

Other names: herceptin, taxotere and carboplatin

Primary outcomes

  1. Number of Patients With Pathologic Complete Response (pCR)

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

    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.

Secondary outcomes

  1. Safety and Tolerability

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

    the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 4, 2005
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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