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Resource-sparing Radiotherapy for Breast Cancer

Phase 3
18 Years
81 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Resource-sparing Radiotherapy for Breast Cancer

Post-mastectomy radiotherapy (PMRT) substantially reduces the risk of loco- regional failure
as shown in several studies and meta-analyses. Two large trials for pre-menopausal
node-positive breast cancer patients treated with mastectomy and chemotherapy showed that
PMRT not only reduced loco- regional failure rates but also improved disease-free and
overall survival rates.

Although the benefit of PMRT is clear, the optimal volume of tissues to be covered by the
radiotherapy fields is controversial. Since the chest wall is the most likely location of
recurrence, there is uniform consensus that the chest wall should be irradiated. However,
areas of controversy exist regarding irradiation of the regional lymph nodes (axillary,
supraclavicular and internal mammary lymph nodes), optimal radiation dose, and

If equivalent results could be achieved by omitting irradiation of the supraclavicular
region in patients receiving adjuvant systemic therapy, this will simplify and expedite
treatment in this patient population. Furthermore, the use of a shortened fractionation
schedule of 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks which has been used in
the UK and Canada for post-mastectomy patients for several decades will shorten the duration
of treatment by reducing the number of patient visits for radiotherapy and increase the
number of patients who can be treated. Treatment will be more convenient for patients and a
reduction in the number of treatments could result in savings for strained health care

This is a randomized comparison of two different radiotherapy field set-ups for
post-mastectomy treatment of locally advanced breast cancer. Patients who have undergone
modified radical mastectomy including axillary lymph node dissection will be randomized to
receive one of two radiotherapy treatment arms, A and B following the completion of adjuvant
chemotherapy. The radiotherapy for treatment Arm A consists of irradiation of the chest
wall only while Treatment Arm B includes irradiation of the chest wall and the ipsilateral
supraclavicular field. Patients on both treatment arms will receive radiation with a
shortened fractionation schedule. Patients will be evaluated for local control, regional
control, survival and treatment toxicity.

Inclusion Criteria:

1. Patients must be older than 18 and less than 81 years of age

2. WHO (ECOG) Performance Status of 0-2

3. Histologically confirmed diagnosis of infiltrating ductal carcinoma of the breast,
lobular carcinoma or mixed (ductal and lobular) type.

Note: Tumor diagnosis will be performed at the participating center according to
the center's routine procedures.

4. Patients must have had a modified radical mastectomy (MRM) in which 6 or more
axillary nodes were removed.

5. All patients should receive adjuvant chemotherapy following MRM. The initiation of
radiation therapy must allow for the full recovery of blood counts (WBC > 3.0 x
109/L, Granulocytes > 1.5 x109/L and platelets > 75 x 109/L).

Note: MRM should have been performed at maximum 3 months prior to the start of
adjuvant chemotherapy.

Special Note: Patients who have not received adjuvant chemotherapy will be required
to receive adjuvant chemotherapy as per Appendix 3 prior to study entry and
initiation of radiotherapy must allow for the full recovery of blood counts (WBC >
3.0 x 109/L, Granulocytes > 1.5 x109/L and platelets > 75 x 109/L MRM should have
been performed within 3 months prior to the start of adjuvant chemotherapy.

6. Patients must have received adjuvant chemotherapy according to one of the two
regimens found in Appendix 3.

7. Negative surgical margins by histopathology at the time of MRM. Note: Negative
surgical margins means that there are no cancer cells at the inked margin of
resection or otherwise at the margins of the mastectomy specimen.

8. The following indicators in the histological samples must be known :

1. Tumor size

2. Tumor site (quadrant, central, axillary tail)

3. Presence of extensive intraductal component (EIC)

4. Estrogen and Progesterone Receptor Status and the method of staining and

5. HER2 Status (optional), if given, the method must be provided.

9. Patients with the following TNM stages, all being M0: pT1 N1, pT2 N1, pT3 N0, pT0 N2,
pT1 N2, pT2 N2, T3 N1, pT3 N2 (see Appendix 4 for TNM Stage)

10. Histological grades 1 - 3 (as per WHO criteria)

11. Patients must consent to return for scheduled treatments and follow up.

12. Written informed consent document signed

Exclusion Criteria:

1. Pathological pN3 (metastasis in 10 or more lymph nodes, clinically apparent internal
mammary metastasis, metastasis in the supraclavicular lymph nodes)

2. Stages IIIB, IIIC and IV (any T4, any N3 or M1)

3. Recurrence of breast cancer following MRM and/or adjuvant chemotherapy.

4. Concomitant primary cancer in the contralateral breast.

5. History of other malignancy except carcinoma in situ of the cervix or non-melanoma
skin cancer

6. Pregnant or breast-feeding

7. Previous chemotherapy other than adjuvant chemotherapy for treatment of the present
breast cancer

8. Other severe concomitant disease that could impact upon the ability to deliver
treatment or increase the risk of toxicity (such as uncompensated congestive heart
failure, unstable coronary heart disease, uncompensated chronic obstructive pulmonary
disease, collagen vascular diseases including systemic lupus erythematosus, systemic
sclerosis, dermatomyositis, and ataxia telangiectasia).

9. Contraindications to radiation therapy (such as previous irradiation of the breast or
chest wall)

10. Severe psychiatric disorder that may interfere with the process of informed consent
and/or treatment or follow-up compliance.

Type of Study:


Study Design:

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

Outcome Measure:

Local control.

Outcome Description:

The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Eduardo Rosenblatt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

International Atomic Energy Agency


United Nations: International Atomic Energy Agency

Study ID:




Start Date:

March 2007

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Radiotherapy
  • Post-mastectomy
  • Molecular characterization
  • Breast Neoplasms