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

Breast Cancer Clinical Trial

Official title:

A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00118053
• Other study ID #: 040412;CDR0000433511
• Secondary ID: P30CA072720CINJ-
• Status: Terminated
• Phase: Phase 2
• First received: July 8, 2005
• Last updated: September 17, 2013
• Start date: April 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• herceptin

Drug:
• carboplatin

• docetaxel

Procedure:
• conventional surgery
Modified radical mastectomy or lumpectomy and axillary node dissection
• radiation therapy
Whole breast or chest wall irradiation (as determined by radiologist)

Locations

Country	Name	City	State
United States	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	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	UMDNJ University Hospital	Newark	New Jersey
United States	Overlook Hospital	Summit	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Aventis Pharmaceuticals, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor Activity as Measured by Response Rate		5 years	No
Secondary	Pathological Complete Response		5 years	No
Secondary	Disease-free Survival		10 years	No
Secondary	Pathologic and Molecular Markers for Predicting Efficacy		5 years	No

External Links

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