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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT00118053
First received: July 8, 2005
Last updated: September 17, 2013
Last verified: September 2013
  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: herceptin
Drug: carboplatin
Drug: docetaxel
Procedure: conventional surgery
Procedure: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Antitumor Activity as Measured by Response Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathological Complete Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Disease-free Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Pathologic and Molecular Markers for Predicting Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: April 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: herceptin
Other Name: trastuzumb
Drug: carboplatin Drug: docetaxel
Other Name: Taxotere
Procedure: conventional surgery
Modified radical mastectomy or lumpectomy and axillary node dissection
Procedure: radiation therapy
Whole breast or chest wall irradiation (as determined by radiologist)

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
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, United States, 08816
CentraState Medical Center
Freehold, New Jersey, United States, 07728
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901-1780
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
Overlook Hospital
Summit, New Jersey, United States, 07902-0220
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Aventis Pharmaceuticals
Investigators
Principal Investigator: Deborah L. Toppmeyer, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier: NCT00118053     History of Changes
Other Study ID Numbers: 040412;CDR0000433511, P30CA072720, CINJ-040412, 0220045191, CINJ-NJ1104
Study First Received: July 8, 2005
Results First Received: September 17, 2013
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
inflammatory breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014