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

Breast Cancer Clinical Trial

— ROSALIE  

Official title:

Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866458
• Other study ID #: OCOG-2022-ROSALIE
• Status: Recruiting
• Start date: March 12, 2024
• Est. completion date: October 2031

Study information

• Verified date: April 2024
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: Adrianne Van Dam
• Phone: 905-527-2299
• Email: avandam[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: October 2031
• Est. primary completion date: October 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Jewish General Hospital	Montréal	Quebec
Canada	CHU de Quebec - Universite Laval	Quebec City	Quebec
Canada	Sunnybrook Health Sciences -Odette Cancer Centre	Toronto	Ontario
Canada	Centre Hospitalier Trois Rivieres Ste-Marie	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ipsilateral breast tumour recurrence (IBTR)	defined as ipsilateral recurrence (invasive or insitu) in the ipsilateral breast or chest wall. Histological evidence of IBTR is required. All such events will be reviewed by a central adjudication committee.	5 years
Secondary	Mastectomy free interval	defined as time from registration to undergoing ipsilateral mastectomy.	5 years
Secondary	Relapse free interval (RFI)	defined as time from registration to recurrence of invasive disease in the ipsilateral breast, regional nodes (axilla, supraclavicular, or internal mammary), distant areas beyond local or regional limits (distant recurrence), and death from breast cancer.	5 years
Secondary	Disease free survival (DFS)	defined as time from registration to in breast invasive tumour recurrence, regional invasive recurrence, distant recurrence, contralateral breast cancer, second primary non-breast cancers, death from breast cancer, and death from non-breast cancer.	5 years
Secondary	Overall survival (OS)	defined as time from registration to death from any cause.	5 years