Moffitt Cancer Center: Clinical Trial 20030

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Clinical Trial 20030

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

Phase: Phase III
Prinicipal Investigator: Iman Washington

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 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

Medications

Not Applicable ()

Inclusion Criteria

Participants must have newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases.

Participants must have been treated by BCS or mastectomy.

Participants treated by BCS or mastectomy and axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm).

Participants treated by BCS and 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 ≥ 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 confirm access to and 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. Endocrine therapy can be given concurrently or following RT.

Participants may or may not have had adjuvant chemotherapy.

RT must be administered within 12 weeks of definitive surgery if the Participant is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 2-8 weeks after the last dose.

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

Participant's age must be ≥ 40 years.

Participant's life expectancy is ≥10 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 micrometastases (pN1Mi, > 0.2 mm and ≤ 2 mm) or isolated tumour cells (pN0i+ >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 not treated with radiation are eligible.)

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 with pT3 or pT4 disease.

Participants who are pregnant.

Participants that have had prior ipsilateral chestwall/thoracic radiation.

Participants treated with neoadjuvant chemo or endocrine therapy for breast cancer.

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.