Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy

Recruiting now · Not applicable

Conditions studied: Estrogen Receptor Negative, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma

In brief

This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery. In ER positive/HER2 negative breast cancers, after endocrine therapy and ablative radiotherapy, when image-guided biopsy shows no residual cancer, patients then receive standard endocrine therapy with no surgery. For patients who have HER2 positive and triple negative breast cancers and standard surgery, after systemic therapy, breast radiotherapy is being eliminated when the pathology from surgery shows no residual cancer.

Key facts

Study ID

NCT02945579

Run by

M.D. Anderson Cancer Center

People needed

120

Starts

2017-01-20

Expected to finish

2028-01-31

Last updated by the study team

2026-03-09

Who can join

Age: 30 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Cohort A1 and A2
• Conditions for patient eligibility: Patients on this portion of the study can receive radiation treatment at any MD Anderson Cancer Center or any outside hospital and 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 [124, 125].
• 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.
• Patient understands that the breast lesion size on final breast imaging must be less than or equal to 2 cm prior to the biopsy procedure being performed on study and if the biopsy shows residual carcinoma the patient will be taken off study.
• Cohort B1 and B2
• Conditions for patient eligibility: Patients on this portion of the study will be limited to receive radiation treatment at MD Anderson Cancer Center or other approved locations and must be enrolled prior to any neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:
• ER and/or PR positive, HER2 negative
• Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion,
• At least 40 years of age.
• Oncotype ≤ 25 if age ≥ 50 years
• Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years.
• Patient agrees to take anti-estrogen therapy and is interested in breast conservation
• 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.
• No history of prior radiation to the area of the breast that would require protocol-mandated treatment
• Cohort C
• Conditions for patient eligibility: Patients on this portion of the study can receive surgical treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:
• Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0 and HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen containing her-2 directed therapy OR Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 (≤ 2 cm), N0, clinical stage M0 and triple negative, receiving any standard routine clinical NST regimen.
• For cohort C patients participating in the optional pretreatment biopsy, the patient should be able undergo biopsy or surgery of the primary tumor site of suspected or proven invasive breast cancer and should be planned to receive neoadjuvant systemic therapy.

You may not qualify if…

• Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1/A2/C; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B1/B2.
• 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 in Cohort A1/A2/B1/B2.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (enrolling)
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Cooper Hospital Univ Med Ctr, MD Anderson at Cooper Voorhees — Voorhees Township, New Jersey, United States (enrolling)
• Queen's Medical Center — Honolulu, Hawaii, United States
• MD Anderson Cancer Center - Banner — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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