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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:

No

Principal Investigator

Deborah L. Toppmeyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

040412;CDR0000433511

NCT ID:

NCT00118053

Start Date:

April 2005

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • inflammatory breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms

Name

Location

Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
UMDNJ University HospitalNewark, New Jersey  07103
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Mountainside Hospital Cancer CenterMontclair, New Jersey  07042
CentraState Medical CenterFreehold, New Jersey  07728
Central Jersey Oncology Center, PA - East BrunswickEast Brunswick, New Jersey  08816