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Nonrandomized Ph II Study of Multimodality Therapy for Stg IIB, IIIA/B, or Initially Presenting Stg IV Breast Cancer w/ Four Cycles of AC Followed by 12 Weeks of Single Agent Paclitaxel w/ or w/o Herceptin Followed by Local Therapy Followed by Weekly Herceptin or No Additional Therapy


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

Thank you

Trial Information

Nonrandomized Ph II Study of Multimodality Therapy for Stg IIB, IIIA/B, or Initially Presenting Stg IV Breast Cancer w/ Four Cycles of AC Followed by 12 Weeks of Single Agent Paclitaxel w/ or w/o Herceptin Followed by Local Therapy Followed by Weekly Herceptin or No Additional Therapy


OBJECTIVES:

- Determine the cardiac and other toxicity of paclitaxel when administered with
trastuzumab (Herceptin) after doxorubicin and cyclophosphamide in women with stage IIB,
IIIA, IIIB, IIIC, or previously untreated stage IV breast cancer.

- Determine whether the addition of paclitaxel with or without trastuzumab to
conventional breast cancer adjuvant therapy (doxorubicin and cyclophosphamide) further
decreases tumor size and the number of positive axillary nodes in these patients.

- Determine the 5-year disease-free survival and overall survival of patients treated
with these regimens.

- Determine whether the initial pathologic response in patients receiving neoadjuvant
therapy correlates with the eventual 5-year disease-free survival or overall survival.

- Compare the number of patients eligible for breast-conserving cancer surgery after
treatment with doxorubicin and cyclophosphamide vs paclitaxel and trastuzumab.

- Correlate clinical and radiographic response rate with pathologic response rate in the
primary tumor and axillary lymph nodes and determine which parameter best determines
the pathologic response rate in patients treated with these regimens.

OUTLINE: Patients are assigned to receive either neoadjuvant therapy (HER-2 overexpressing
and nonoverexpressing patients) or adjuvant therapy (HER-2 overexpressing patients only).

- Neoadjuvant therapy: Patients assigned to receive neoadjuvant therapy receive one of
two treatment regimens.

- Regimen I (HER-2 nonoverexpressing patients or HER-2 overexpressing patients who
refuse trastuzumab (Herceptin) therapy): Patients receive doxorubicin IV and
cyclophosphamide IV over 30 minutes and paclitaxel IV over 3 hours on day 1 every
3 weeks for a total of 4 courses. Patients then undergo surgery with or without
adjuvant radiotherapy and/or oral tamoxifen.

- Regimen II (HER-2 overexpressing patients only): Patients receive doxorubicin and
cyclophosphamide as in regimen I. After completion of course 4, patients receive
paclitaxel IV and trastuzumab IV over 90-150 minutes weekly on weeks 13-24.
Patients then undergo surgery with or without adjuvant radiotherapy. Patients then
receive trastuzumab IV over 30 minutes weekly on weeks 29-69 if they did not
receive radiotherapy or on weeks 36-76 if they did receive radiotherapy.

- Adjuvant therapy: Patients who are assigned to receive adjuvant therapy (HER-2
overexpressing patients only) receive doxorubicin IV and cyclophosphamide IV over 30
minutes on day 1 every 3 weeks for a total of 4 courses. After completion of course 4,
patients receive paclitaxel IV and trastuzumab IV over 90 minutes weekly on weeks
13-24. Patients then may undergo radiotherapy followed by trastuzumab IV over 30
minutes weekly on weeks 29-69 if they did not receive radiotherapy or on weeks 36-76 if
they did receive radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 125 patients (100 in the neoadjuvant group and 25 in the
adjuvant group) will be accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage
IV primary carcinoma of the breast

- Fine needle aspiration, core needle biopsy, or incisional biopsy allowed

- No excisional biopsy

- Any of the following:

- T2, N1 or T3, N0

- Any T with N2 (including axillary lymph nodes matted to one another) or N3

- Any T4, including inflammatory breast cancer

- Adjuvant patients with at least 4 positive lymph nodes and HER-2
overexpressing tumor

- Supraclavicular or infraclavicular positive lymph nodes without distant
metastases

- Distant metastases with measurable disease in breast or lymph nodes

- Synchronous bilateral primary breast cancer allowed if the more serious cancer meets
entry criteria

- Measurable or evaluable disease

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- Not specified

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 9 g/dL

Hepatic:

- Bilirubin less than 1.5 times normal

Renal:

- Creatinine less than 1.5 times normal

Cardiovascular:

- LVEF normal by resting nuclear ventriculogram

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior malignancies except:

- Effectively treated squamous cell or basal cell skin cancer

- Carcinoma in situ of the cervix that has been curatively treated by surgery
alone

- Nonbreast malignancy from which patient has been disease-free for 5 years and is
at low risk of recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the cardiac and other toxicity of weekly Taxol given with weekly Herceptin when delivered immediately following four cycles of standard dose AC

Outcome Time Frame:

15 weeks from start of treatment

Safety Issue:

Yes

Principal Investigator

Lisa A. Carey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC 9818

NCT ID:

NCT00006110

Start Date:

December 1998

Completion Date:

April 2013

Related Keywords:

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

Name

Location

Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570