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Clinical Trial 20030

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03488693

Phase: Phase III
Principal Investigator: Washington, Iman

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node or T3N0 Positive Breast Cancer

Summary

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

Objective

To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.

Treatments

Therapies

Radiotherapy; Surgery

Medications

Not Applicable ()

Inclusion Criteria

Participants must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases staged as per site standard of care.

Participants must have been treated by BCS or mastectomy with clear margins of excisions. Patients treated by BCS with focally positive margins for invasive breast cancer or DCIS are eligible if additional surgery is not possible, e.g. posterior margin positive and deep resection margin abuts the chest wall or anterior margin positive and superficial resection margin abuts the skin. Boost radiotherapy must be administered for positive margins as described above. Post-mastectomy positive margins for invasive breast cancer and/or DCIS is not allowed. Multifocal disease and multicentric disease are allowed.

Patients with T3NO disease are eligible

Patients with disease limited to nodal micrometastases are eligible.

Participants with nodal macrometastases (> 2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm).

Participants with nodal macrometastases treated by SLNB alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm).

Participants treated by mastectomy and SLNB alone must have only 1 positive axillary node (macrometastases, > 2 mm).

Participants must be ER greater than or equal to 1% and HER2 negative on local testing

Participants must have an Oncotype DX recurrence score >Participant must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted

Participant must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted.

Participants must have had endocrine therapy initiated or planned for 5 years or more. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT.

Participants may or may not have had adjuvant chemotherapy.

RT must be administered within 16 weeks of definitive surgery if the Participant is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose.

Participant's ECOG performance status must be 0, 1 or 2.

Participant's age must be greater than or equal to 35 years

For the first 736 eligible English or French-speaking subjects who have agreed to optional questionnaire completion: Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life, health utilities and lost productivity questionnaires in either English or French

Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements

Participants must be accessible for treatment and follow-up. Investigators must assure themselves the Participants randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of Participant randomization.

Women of childbearing potential must have agreed to use an effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months.

Exclusion Criteria

Participants with nodal disease limited to isolated tumour cells (pN0i+ > Patients with pT3N1 and pT4 disease

Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Participants with synchronous or previous ipsilateral LCIS are eligible.)

Synchronous or previous contralateral invasive breast cancer. (Participants with contralateral DCIS are eligible unless previously treated with radiation.)

History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for >/= 5 years.

Participants who are pregnant.

Participants that have had prior ipsilateral chestwall/thoracic radiation.

Participants treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.

Participants with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.) which would preclude RT.

Participants with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the Participant from participating or to be managed according to the protocol (according to investigator's decision).

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.