Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50+
SponsorOntario Clinical Oncology Group (OCOG)

About this trial

To de-escalate radiation therapy in women with breast cancer.

Eligibility criteria

Qualifiers

Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).

Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.

Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.

Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.

Disqualifiers

Age less than 50 years.

Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).

Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).

Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

352 Participants
are grouped into 1 trial group

Sponsors and collaborators

Ontario Clinical Oncology Group (OCOG)

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Hamilton Health Sciences Corporation

Collaborator