Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 80	NCI, Pharmaceutical / Industry	UCLA-9911084 AVENTIS-GIA-11156, GENENTECH-H2269s, NCT00068341

Objectives

1. Compare the objective response rate of women with locally advanced breast cancer treated with neoadjuvant docetaxel and carboplatin with vs without trastuzumab (Herceptin®).
2. Compare the toxic effects of these regimens in these patients.
3. Compare disease-free and overall survival in patients treated with these regimens.
4. Determine the molecular characteristics of tumors that are responsible for drug susceptibility and drug interactions in patients treated with these regimens.
5. Provide additional prognostic information about these patients for conventional pathology studies.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed infiltrating adenocarcinoma of the breast
  • Primary disease greater than 2 cm (T₂, T₃) OR skin and chest wall involvement (T₄)
  • Any N
  • No evidence of metastasis (M0)
  • Diagnosed within the past 3 months



• HER2/neu status determined by fluorescent in situ hybridization



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• No prior trastuzumab (Herceptin®)
• No other prior or concurrent immunotherapy
• No prior or concurrent gene therapy

Chemotherapy

• No prior docetaxel
• No prior carboplatin
• No other prior or concurrent chemotherapy

Endocrine therapy

• No prior or concurrent antitumor hormonal therapy

Radiotherapy

• No prior radiotherapy to the involved breast
• No concurrent radiotherapy to an indicator lesion

Surgery

• Not specified

Other

• More than 5 years since any prior drug therapy for breast cancer
• No other concurrent experimental drugs
• No other concurrent anticancer treatment

Patient Characteristics:

Age

• 18 to 80

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• At least 1 year

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)
• SGOT and SGPT ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 1.5 times ULN

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• LVEF normal by MUGA or echocardiogram

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergy to polysorbate or castor oil
• No ongoing active infection
• No concurrent life-limiting disease
• No other malignancy within the past 5 years that could affect the diagnosis or assessment of breast cancer, except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• No grade 2 or greater pre-existing peripheral neuropathy

Expected Enrollment

A total of 75 patients will be accrued for this study within 4 years.

Outcomes

Objective response rate after completion of neoadjuvant therapy (4 courses)
Toxicity after completion of neoadjuvant and adjuvant therapies

Disease-free survival at 1, 2, and 5 years
Overall survival at 1, 2, and 5 years

Outline

This is a randomized, multicenter study. Patients are stratified according to age, initial tumor size, tumor type (T₂ vs T₃ vs T₄), presence of clinically positive lymph nodes (yes vs no), and mother's family history (positive vs negative).

• Neoadjuvant therapy: All patients receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1 or 2. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who are HER2/neu positive are randomized to 1 of 2 concurrent trastuzumab (Herceptin®) treatment arms.
  • Arm I: Patients receive trastuzumab (concurrently with chemotherapy) IV over 30-90 minutes on days 1, 8, and 15. Trastuzumab repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  
  
  
  • Arm II: Patients do not receive concurrent trastuzumab. Patients receive neoadjuvant chemotherapy only.
  
  
  



• Surgery: Within 3 weeks after completion of course 4 of neoadjuvant therapy, patients with responding disease undergo definitive surgery.



• Adjuvant therapy: Within 4-6 weeks after surgery, patients with responding disease receive 4 additional courses of docetaxel and carboplatin as during neoadjuvant chemotherapy. All HER2/neu positive patients also receive trastuzumab IV once weekly for 12 weeks and then every 3 weeks for 40 weeks (total of 52 weeks of trastuzumab therapy).

Within 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy.

Estrogen-receptor positive patients receive oral tamoxifen once daily for 5 years.

Patients are followed annually for 5 years.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Helena Chang, MD, PhD, Principal investigator		Ph: 310-794-5640; 888-798-0719 Email: hchang@mednet.ucla.edu

Registry Information
Official Title		Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer
Trial Start Date		2003-07-15
Trial Completion Date		2012-05-01 (estimated)
Registered in ClinicalTrials.gov		NCT00068341
Date Submitted to PDQ		2003-07-15
Information Last Verified		2008-10-21
NCI Grant/Contract Number		CA16042

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