Methods: Participants, Interventions and
Outcomes
Study Setting {9}
The trial is supported currently by intramural funding from Tata Medical
Center and has received extramural funding from the NAG foundation. The
study has been initiated at the Department of Radiation Oncology at Tata
Medical Center. Site initiation has been done at CMC Vellore and SGPGI
Lucknow. Combining all three centres, approximately 100 patients
annually undergo adjuvant radiotherapy. As the eligibility criteria are
very inclusive we expect that most breast cancer patients requiring
adjuvant radiotherapy will be eligible for inclusion in this study.
Other large academic centers treating a substantial number of breast
cancer patients will be approached for participation in the future.
Eligibility Criteria {10}
Patient Eligibility
Criteria:
Inclusion criteria are deliberately kept non-restrictive so that the
results can be generalizable to the Indian population of breast cancer
patients. Patients who have undergone curative intent surgery in the
form of a mastectomy or breast conservation surgery with clear margins
for non-metastatic invasive breast cancers are eligible for this trial.
An adequate axillary clearance or an appropriate axillary staging
procedure like sentinel lymph node biopsy should have been performed.
All patients undergoing breast conservation or neoadjuvant chemotherapy
will be eligible. Patients will be eligible for inclusion after
mastectomy if they have the following characteristics:
- T3 - T4 tumors
- > 3 axillary lymph nodes
- T0-T2 tumour with 0 - 3 axillary lymph nodes with a Cambridge Score of
3 or more(30).
The primary exclusion criteria are patients with carcinoma in situ,
non-epithelial breast primaries and metaplastic carcinomas. Patients
with a residual internal mammary node or supraclavicular fossa node
prior to radiotherapy will also be excluded as they may be eligible for
an additional boost to the residual node. Patients with prior
radiotherapy to the breast or those planned for concurrent chemotherapy
will also be excluded.
Trial Center
Requirements
High volume centers treating more than 150 breast cancer patients
annually with facilities for surgery, radiotherapy, chemotherapy as well
as a functional pathology and radiology services will be required.
Ideally there should be a dedicated multi-disciplinary team comprising
of surgeons, clinical/radiation oncologists, medical oncologists,
pathologists and radiologists treating breast cancer. The center should
report mammograms using the Breast Imaging Reporting and Data (BIRAD)
system. Breast pathology services should have accredited services for
evaluation of Estrogen receptor, Progesterone receptor and Her2neu
receptor status with immunohistochemistry.
For this study, breast cancer patients must be simulated through a
volumetric imaging technique. The trial centres must fulfil the trial
quality assurance requirements as outlined in the Radiotherapy Quality
Assurance (RTQA) document.
Who will take informed consent
{26a}
Informed consent will be obtained from the patient by the investigators
or designated authorized person. Written informed consent will be
obtained on the informed consent form.
Additional consent provisions for collection and use of
participant data and biological specimens
{26b}
Biospecimen banking in the form of plasma and buffy coat will be done
for consenting patients. A separate consent will be obtained by the
investigators for this. The biobanking consent form used in TMC will be
used for specimen biobanking in Tata Medical Center. For other centres,
biobanking of biological specimens will be done at investigators’
discretion following institutional policy.