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"A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

"A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"

1. Partial Breast Irradiation with concurrent chemotherapy (various regimens. Subjects
will receive Segmental Mastectomy (Lumpectomy)

2. Medical Oncology Evaluation

3. Consent/Registration Pre-RT evaluation

4. Simulation/Treatment Planning

5. Chemo-Radiation Therapy:

ddAC, Std AC, TAC, TC, TCH or TH Concurrent with PBI - (270 cGy per fraction for 15
fractions). RT may start up to 7days prior to C1D1, but no later than 7 days after C1D1
(+/- 7 days of C1D1 radiation may start)

6. Further chemotherapy, hormonal therapy or biologic therapy at the medical oncologist's

7. F/U Schedule

Inclusion Criteria

Eligibility Criteria:

Each of the criteria in the following section must be met in order for a patient to be
considered eligible for registration.

- Patient must be older than 18 years of age

- Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma
of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes
(pathologic T1-2, pathologic N0 -N1, M0). Patients with squamous carcinomas or
sarcomas of the breast cancer are NOT eligible.

- Patient must have a history and physical within six weeks prior to the start of any
protocol therapy.

- Patient must have had a bilateral mammogram prior to surgery.

- Patients must have undergone a segmental mastectomy (SM) with a level I and ll
axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM
must be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive
ductal carcinoma. Patients who have post-operative margins which are negative but
less than 2mm will be considered eligible if the surgeon states that the margin in
question could not be improved.

- Patient must have a Medical Oncology consult and be recommended to receive one of the
following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and
Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin
and Trastuzumab (TCH) prior to registration. The use of additional chemotherapy,
hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the
medical oncologist.

- Patients must be registered such that radiation therapy begins no sooner than 7 days
prior to, but no later than 7 days after, day 1 of cycle 1 (C1D1). Patient must start
chemotherapy and radiation less than 14 weeks from the last breast surgical

- Patients must NOT have received any neo adjuvant chemo or hormonal therapy for the
current cancer.

- Patients must have a performance status 0 or 1 by ECOG criteria

- Patients must not have received prior radiation therapy to the involved breast at any
time for any reason.

- Any patient with active local-regional disease prior to registration is not eligible.

- No other prior malignancy is allowed except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or any other cancer from which
the patient has been disease-free for 5 years.

- Patients must not be pregnant due to the potential for fetal harm as a result of this
treatment regimen. Women of child-bearing potential must use effective non hormonal
contraception while undergoing radiation therapy. Women of child-bearing potential
must also have a negative pregnancy test within six weeks prior to start of protocol

- Patients must not have a serious medical or psychiatric illness which prevents
informed consent or compliance with treatment.

- All patients must be informed of the investigational nature of this study and given
written informed consent in accordance with institutional and federal guidelines.

Type of Study:


Study Design:

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

Outcome Measure:

To assess the potential acute and late skin and subcutaneous toxicities of partial breast irradiation concurrent with chemotherapy.

Outcome Time Frame:

Treatment then 5 year follow-up schedule

Safety Issue:


Principal Investigator

Richard Zellars, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

July 2017

Related Keywords:

  • Breast Cancer
  • cosmetic
  • effect
  • breast
  • irradiation
  • concurrent
  • chemotherapy
  • potential acute
  • late skin
  • subcutaneous toxicities
  • Breast Neoplasms



The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231