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Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial

Phase 2
18 Years
Open (Enrolling)
Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Mucinous Ductal Breast Carcinoma, Papillary Ductal Breast Carcinoma, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Tubular Ductal Breast Carcinoma

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Trial Information

Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial


I. Freedom from local failure and freedom from regional failure.


I. Acute toxicity and late toxicity using previously published toxicity scales. II. To
identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest
walls when treated with accelerated, hypofractionated radiotherapy.

III. To correlate toxicity, cosmesis, and local control with molecular markers.


Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days)
within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months
for 3 years, every 6-12 months for 2 years, and then annually thereafter.

Inclusion Criteria:

- Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies;
invasive lobular carcinomas are allowed

- American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3,
T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive
carcinoma of the breast treated with mastectomy and either sentinel node biopsy or
axillary dissection; inflammatory carcinoma (T4d) is allowed

- Patients with locally advanced breast cancer on clinical exam and diagnostics ( > 3
cm and/or clinically node-positive) who have mastectomy after induction chemotherapy
are allowed

- Multifocal/multicentric disease is allowed

- Negative inked histologic margins of mastectomy (no invasive cells at margin) or
positive margin at pectoralis fascia or skin

- Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time
relative to the radiation at the discretion of the treating physician

- Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be
delivered first, followed by radiation therapy beginning 21-63 days after the last
cycle of chemotherapy or the radiation therapy can be delivered first and the
chemotherapy can be delivered no earlier than 21 days post radiation therapy;
neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after
mastectomy or after any adjuvant chemotherapy as described above

- Chest wall reconstruction is allowed

- The patient must be enrolled and have treatment planning between 14-63 days from date
of last surgery or last cycle of chemotherapy, and radiation must start within 21-63
days of date of last surgery or last cycle of chemotherapy

- Signed study-specific informed consent form prior to study entry

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- Patient with distant metastases (M1)

- Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and
patients with non-epithelial breast malignancies such as sarcoma or lymphoma

- Patient with T1N0 or T2N0 disease

- Prior radiation therapy to the chest

- Patients with collagen vascular diseases, specifically systemic lupus erythematosus,
scleroderma, or dermatomyositis

- Patients with co-existing medical conditions with life expectancy < 2 years

- Patients with psychiatric (with the possible exception of incompetence as defined by
New Jersey [NJ] law) or addictive disorders that would preclude obtaining informed

- Other malignancy, except non-melanomatous skin cancer, < 5 years prior to
participation in this study; the disease-free interval from any prior carcinoma must
be continuous

- Women who are pregnant or lactating due to potential exposure of the fetus to RT and
unknown effects of RT to lactating females

- Women who are able to conceive and unwilling to practice an effective method of birth
control; women of childbearing potential must have a negative urine or serum
pregnancy test within 7 days prior to treatment

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to local, regional, and/or distant failure

Outcome Description:

Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.

Outcome Time Frame:

Up to 5 years after dose of last treatment

Safety Issue:


Principal Investigator

Atif Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Inflammatory Breast Cancer
  • Invasive Ductal Breast Carcinoma
  • Invasive Lobular Breast Carcinoma
  • Mucinous Ductal Breast Carcinoma
  • Papillary Ductal Breast Carcinoma
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Tubular Ductal Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular
  • Inflammatory Breast Neoplasms



Cancer Institute of New Jersey New Brunswick, New Jersey  08901