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Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial



- 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.


- To measure cosmesis using the Harvard cosmesis scale in patients who have undergone

- 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

- 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

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

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.

Inclusion Criteria


- 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

- 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

- 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


- 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


- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Loco-regional control as assessed by physical examination, mammography, and other relevant imaging

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Atif Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • invasive ductal breast carcinoma
  • invasive lobular breast carcinoma
  • medullary ductal breast carcinoma with lymphocytic infiltrate
  • mucinous ductal breast carcinoma
  • papillary ductal breast carcinoma
  • tubular ductal breast carcinoma
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903