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NCT05866458 | RECRUITING | Breast Cancer

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

Ontario Clinical Oncology Group (OCOG)

Brief Summary:

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

Condition or disease

Breast Cancer

Detailed Description:

The study is a prospective, multi-center, single arm cohort study of omission of adjuvant whole breast radiation therapy (WBRT) following breast conserving surgery (BCS) in patients with a pathological complete response (pCR) following neoadjuvant chemotherapy (NAC). Eligible and consenting female patients with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, who have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (ypT0N0) will be enrolled to the study and followed. The first analysis is planned when follow-up is a median of 5 years. Study participants will not receive adjuvant WBRT, the current standard of care. The primary outcome is ipsilateral breast tumour recurrence (IBTR) at median 5-year follow-up. Study participants will be followed and assessed for local recurrence, regional recurrence, distant recurrence, DFS and OS. In addition, any additional breast cancer treatments received by the participant for the first recurrence event including repeat BCS, mastectomy, additional systemic therapy and radiation therapy (RT) will be documented. The planned sample size is 352 study participants.

Study Type : OBSERVATIONAL
Estimated Enrollment : 352 participants
Official Title : Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
Actual Study Start Date : 2024-03-12
Estimated Primary Completion Date : 2031-10
Estimated Study Completion Date : 2031-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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 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.
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy

Location Details

NCT05866458

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Canada, Ontario

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

RECRUITING

Canada, Ontario

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada, P7B 6V4

RECRUITING

Canada, Ontario

Sunnybrook Health Sciences -Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

RECRUITING

Canada, Quebec

Jewish General Hospital

Montréal, Quebec, Canada, H3T 1E2

RECRUITING

Canada, Quebec

Quebec Chu - University Laval

Quebec City, Quebec, Canada, G1R 2J6

RECRUITING

Canada, Quebec

Lanaudière Hospital Center

Saint-Charles-Borromée, Quebec, Canada, J6E 6J2

RECRUITING

Canada, Quebec

Center Hospitalier Trois Rivieres Ste-Marie

Trois-Rivières, Quebec, Canada, Conquest