Clinical trial NCT00118053: Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
Official title: A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: inflammatory breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Aventis Pharmaceuticals
First posted: 2005-07-11
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Antitumor Activity as Measured by Response Rate
timeFrame: 5 years
Secondary outcomes:
measure: Pathological Complete Response
timeFrame: 5 years
measure: Disease-free Survival
timeFrame: 10 years
measure: Pathologic and Molecular Markers for Predicting Efficacy
timeFrame: 5 years
Other outcomes:
Locations:
city: East Brunswick
country: United States
facility: Central Jersey Oncology Center, PA - East Brunswick
state: New Jersey
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: Montclair
country: United States
facility: Mountainside Hospital Cancer Center
state: New Jersey
city: Morristown
country: United States
facility: Carol G. Simon Cancer Center at Morristown Memorial Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: Newark
country: United States
facility: UMDNJ University Hospital
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Deborah L. Toppmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: