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

Sponsors and Collaborators:	Cancer Institute of New Jersey National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00118053

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Biological: trastuzumab Drug: carboplatin Drug: docetaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Docetaxel Trastuzumab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Antitumor activity [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pathological complete response [ Designated as safety issue: No ]
Disease-fee survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Pathologic and molecular markers for predicting efficacy [ Designated as safety issue: No ]

Estimated Enrollment:	43
Study Start Date:	April 2005
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118053

Locations

United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, United States, 08816
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Overlook Hospital
Summit, New Jersey, United States, 07902-0220
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901-1780
CentraState Medical Center
Freehold, New Jersey, United States, 07728

Sponsors and Collaborators

Cancer Institute of New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Deborah L. Toppmeyer, MD

Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000433511, CINJ-040412, CINJ-5191, CINJ-NJ1104
Study First Received:	July 8, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00118053 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Docetaxel
Inflammatory Breast Cancer
Skin Diseases
Adjuvants, Immunologic

Trastuzumab
Breast Neoplasms
Carboplatin
Breast Diseases

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Trastuzumab
Breast Neoplasms
Carboplatin
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 09, 2009