Radiation Therapy in Treating Women With Early Stage Breast Cancer

Rutgers The State University of New Jersey

Status and phase

Active, not recruiting

Phase 2

Conditions

Breast Cancer

Treatments

Radiation: whole breast irradiation

Radiation: External beam boost

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00909909

Pro20170001671

0220090059 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

CDR0000643276 (Other Identifier)

040807 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.

Full description

OBJECTIVES:

Primary

To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.

Secondary

To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
To identify co-variates responsible for poor cosmetic outcome in these patients.

OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.

Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).

Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.

After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.

Enrollment

200 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer, including 1 of the following subtypes:
- Ductal carcinoma in situ
- Invasive ductal carcinoma
- Invasive lobular carcinoma
- Medullary carcinoma
- Papillary carcinoma
- Colloidal (mucinous) carcinoma
- Tubular carcinoma
Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)
- Tumor size ≤ 5 cm
Breast considered technically satisfactory for radiotherapy
Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
- Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen
Unifocal or multifocal (confined to 1 quadrant; tumors < 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy
No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
No evidence of suspicious microcalcifications in the breast before the start of radiotherapy
- If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative
No more than 9 positive axillary lymph nodes
No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
No Paget disease of the nipple
No skin involvement, regardless of tumor size
No distant metastases
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Pre- or post-menopausal
ECOG performance status 0-1
No co-existing medical condition that would limit life expectancy to < 2 years
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous)
No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
No psychiatric or addictive disorder that would preclude obtaining informed consent

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior radiotherapy for the current breast cancer
No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy
Chemotherapy allowed provided the following criteria are met:
- Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost)
- Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation)
Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed
- May be initiated before, during, or after radiotherapy
No other concurrent chemotherapy, immunotherapy, or experimental medications