No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Female
Study type
Observational
Participants needed
352 (estimated)
Sponsor
Ontario Clinical Oncology Group (OCOG) · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer who have no lymph node involvement. Participants will undergo a treatment to see if they can avoid radiation after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman diagnosed with clinical T1-3 N0 breast cancer.
I have had negative lymph nodes shown by imaging tests.
I have received at least 8 weeks of neoadjuvant chemotherapy.
My tumor bed has a marker clip placed before or during chemotherapy.
I had a lumpectomy with complete removal of the tumor.
My final pathology shows no residual cancer in the breast or lymph nodes.
You may not be able to join if
I am under 50 years old.
I have inflammatory breast cancer or cancer that invades the skin or chest wall.
I have multiple cancerous areas in one breast.
I have a history of breast cancer in the same or other breast.
I have simultaneous in-situ or invasive breast cancer in the other breast.
I carry a BRCA genetic mutation or another related mutation.
I have had other types of cancer that were not fully treated.
I cannot complete the entire course of neoadjuvant therapy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
To de-escalate radiation therapy in women with breast cancer.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
3. Treated with a minim…
Inclusion Criteria:
1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
6. Final pathology demonstrating a pCR \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\].
Exclusion Criteria:
1. Age less than 50 years.
2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
5. Synchronous contralateral in-situ or invasive breast cancer.
6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.
7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years.
8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).
9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.
10. Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
11. ECOG (Eastern Cooperative Oncology Group) performance status \> 3.
12. Inability to provide informed consent.
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