Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer

NCT ID: NCT00118053

Last Updated: 2013-11-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-12-31

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of trastuzumab (Herceptin^®), docetaxel, and carboplatin, as measured by tumor response rate, in women with previously untreated HER2/neu-positive stage IIB, IIIA, IIIB, or IIIC or inflammatory breast cancer.

Secondary

• Determine the pathological complete response in patients treated with this regimen.
• Determine the disease-free survival of patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.
• Determine pathologic and molecular markers for predicting efficacy of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

• Course 1 (days 1-28): Patients receive trastuzumab (Herceptin^®) IV over 30-90 minutes on days 1, 8, 15, and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 8.
• Course 2-6: Patients receive trastuzumab IV over 30 minutes on days 1, 8, and 15 during courses 2-5 and on days 1, 8, 15, and 22 during course 6. Patients also receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 5 additional courses (6 courses total) in the absence of disease progression or unacceptable toxicity.

Three weeks after completion of course 6, patients undergo restaging. Patients with local operable disease undergo modified radical mastectomy or lumpectomy and axillary node dissection followed by radiotherapy. Patients also receive trastuzumab IV once every 3 weeks for up to 52 weeks of total treatment (including the 6 courses of trastuzumab, docetaxel, and carboplatin) in the absence of disease progression or unacceptable toxicity. Patients who do not have local operable disease continue to receive trastuzumab as above.

PROJECTED ACCRUAL: A total of 13-43 patients will be accrued for this study.

Conditions

Breast Cancer

Keywords

inflammatory breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel, Carboplatin and Trastuzumab

A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.

• Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
• If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.

Group Type: EXPERIMENTAL

herceptin

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Modified radical mastectomy or lumpectomy and axillary node dissection

radiation therapy

Intervention Type: PROCEDURE

Whole breast or chest wall irradiation (as determined by radiologist)

Interventions

herceptin

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

conventional surgery

Modified radical mastectomy or lumpectomy and axillary node dissection

Intervention Type: PROCEDURE

radiation therapy

Whole breast or chest wall irradiation (as determined by radiologist)

Intervention Type: PROCEDURE

Other Intervention Names

trastuzumb; Taxotere

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer, meeting 1 of the following stage criteria:

• Stage IIB (T3, N0)
• Stage IIIA (N0-N2)
• Stage IIIB (T4, N0-2)
• Stage IIIC
• Inflammatory breast cancer
• HER2/neu-positive disease by fluorescence in situ hybridization
• Biopsy-accessible tumor
• Measurable disease by physical examination or x-ray
• No stage IV disease
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• At least 8 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Meets 1 of the following criteria:

• SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal
• SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
• SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN
• Bilirubin normal

Renal

• Creatinine normal
• No pre-existing clinically significant renal disease that is not related to the malignancy

Cardiovascular

• Ejection fraction ≥ 50% by MUGA
• No pre-existing clinically significant cardiac disease that is not related to the malignancy
• No history of congestive heart failure

Pulmonary

• No pre-existing clinically significant pulmonary disease that is not related to the malignancy

Gastrointestinal

• No severe malnutrition
• No intractable emesis

Neurologic

• No pre-existing clinically significant neurologic disease that is not related to the malignancy
• No peripheral neuropathy ≥ grade 2

• No nerve damage from diabetes

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective non-hormonal contraception during and for 4 weeks after completion of study treatment
• No known allergic reaction to study drugs
• No active infection
• No other malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other pre-existing clinically significant disease that is not related to the malignancy
• No other serious or significant medical condition that would preclude study participation
• No other contraindication to study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent immunotherapy

Chemotherapy

• No prior chemotherapy for the malignancy
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy for the malignancy

Radiotherapy

• No concurrent radiotherapy

Surgery

• No concurrent surgery for the malignancy

Other

• More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing products
• No other concurrent investigational or commercial agents or therapies for the malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah L. Toppmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Central Jersey Oncology Center, PA - East Brunswick

East Brunswick, New Jersey, United States

CentraState Medical Center

Freehold, New Jersey, United States

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, United States

Mountainside Hospital Cancer Center

Montclair, New Jersey, United States

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

UMDNJ University Hospital

Newark, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

Countries

United States

Related Links

http://www.clinicaltrials.gov/ct2/show/NCT00118053

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINJ-040412

Identifier Type: OTHER

Identifier Source: secondary_id

0220045191

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ-NJ1104

Identifier Type: OTHER

Identifier Source: secondary_id

040412;CDR0000433511

Identifier Type: -

Identifier Source: org_study_id