Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Procedure: adjuvant therapy

Radiation: radiation therapy

Drug: paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00006256

CWRU2199

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells.

PURPOSE: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.

Full description

OBJECTIVES:

Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy.
Assess the cosmetic results of breast conservation after this treatment in these patients.
Determine the pulmonary toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.

Enrollment

44 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Stage II or III invasive breast cancer
Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required
No prior contralateral breast cancer
No metastatic disease
Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy
Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks
Candidate for definitive radiotherapy
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm3
Granulocyte count at least 2,000/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
ALT/AST no greater than 1.5 times ULN

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

No concurrent poorly controlled ischemic heart disease or congestive heart failure
LVEF at least 45% by MUGA scan or echocardiogram

Pulmonary:

No concurrent severe chronic obstructive or restrictive pulmonary disease

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No concurrent severe medical or psychiatric illness
No concurrent severe diabetes mellitus
No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision

PRIOR CONCURRENT THERAPY:

Biologic therapy: