Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy

Overview

About this study

The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 50 participants will be enrolled on this multicenter study. Up to 50 may take part at MD Anderson.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

Patients may be enrolled prior to, during, or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:

  • Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on initial ultrasound), clinical stage M0.
  • HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER/PR < 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard routine clinical NST regimen.
  • Patient desires breast conserving therapy.
  • Age 40 years or older.  This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences [104, 105].
  • Female sex.
  • If the patient has a history of a prior non-breast  cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.
  • Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.

Exclusion Criteria:

  • Radiologic evidence for a stage T3 or clinical stage T4 breast cancer.
  • Clinical or pathologic evidence for distant metastases.
  • Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.
  • Clinical evidence of progression of disease > 20% in the breast or new evidence of nodal metastases.
  • Patient is known to be pregnant.
  • Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Judy Boughey, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20438440

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