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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
herceptin
carboplatin
docetaxel
conventional surgery
radiation therapy
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Central Jersey Oncology Center, PA - East Brunswick
  • CentraState Medical Center
  • Cancer Institute of New Jersey at Hamilton
  • Mountainside Hospital Cancer Center
  • Carol G. Simon Cancer Center at Morristown Memorial Hospital
  • Saint Peter's University Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • UMDNJ University Hospital
  • Overlook Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel, Carboplatin and Trastuzumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Antitumor Activity as Measured by Response Rate

Secondary Outcome Measures

Pathological Complete Response
Disease-free Survival
Pathologic and Molecular Markers for Predicting Efficacy

Full Information

First Posted
July 8, 2005
Last Updated
September 17, 2013
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI), Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00118053
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI), Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel, Carboplatin and Trastuzumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
herceptin
Other Intervention Name(s)
trastuzumb
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Modified radical mastectomy or lumpectomy and axillary node dissection
Intervention Type
Procedure
Intervention Name(s)
radiation therapy
Intervention Description
Whole breast or chest wall irradiation (as determined by radiologist)
Primary Outcome Measure Information:
Title
Antitumor Activity as Measured by Response Rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Pathological Complete Response
Time Frame
5 years
Title
Disease-free Survival
Time Frame
10 years
Title
Pathologic and Molecular Markers for Predicting Efficacy
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L. Toppmeyer, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Jersey Oncology Center, PA - East Brunswick
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
CentraState Medical Center
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Mountainside Hospital Cancer Center
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962-1956
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901-1780
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
UMDNJ University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902-0220
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.gov/ct2/show/NCT00118053
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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