RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT02945579 Eliminating Breast Cancer Surgery in Exceptional Responders to Neoadjuvant Systemic Therapy

Status

Open

Description

The historical rationale for breast conserving therapy has been to use surgery to remove gross disease followed by radiation to remove clinically occult disease. This strategy is highly effective. With advances in NST, chemotherapy now effectively eliminates gross disease in a large proportion of patients. It appears that we can now identify patients who will be found to have a pCR based on post-chemo, pre-surgery large volume, vacuum- assisted core biopsy. We hypothesize that these patients, identified as biopsy negative after chemotherapy, do not need surgery because chemotherapy has already removed the gross disease, effectively obviating the need for surgery. We therefore propose to omit surgery because systemic therapy has removed the gross disease, and treat these patients with standard radiotherapy alone following biopsy-negative response to chemotherapy. Further, definitive radiation without surgical resection with or without systemic therapy has been proven effective for several other malignant disease sites including some stages of esophageal, anal, laryngeal, prostate, and lung carcinoma.

Objective

The primary objective of this study is to determine the 6 mo, 1, 2, 3, and 5-year biopsy confirmed ipsilateral breast tumor recurrence rate among patients who do not undergo surgery. recurrence rate (IBTR, invasive and/or in situ) among patients who do not undergo surgery.

Treatment

Neoadjuvant Systemic Therapy (NST) Breast Biopsy following NST Radiation Therapy: For clinically node-negative patients, the prescription dose will be 40.05 Gy in 15 fractions delivered to the whole breast on consecutive treatment days. A treatment day is defined as a normal business day, typically Monday – Friday excluding institutional holidays. The prescription dose for the tumor bed boost for patients assigned to HF- WBI will be 14 Gy in 7 fractions delivered on consecutive treatment days. The boost will begin on the treatment day following completion of whole breast irradiation.

Conditions

Other

Phases

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Lesnikoski, Beth

Practice

Breast

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center

Eligibility

Inclusion: - Conditions for patient eligibility: 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: - 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.

Nct ID Number

NCT02945579

Secondary Trial ID Number

2016-0046/EXCEPTIONALRESPONDER

Keywords

Treatment

More Information

clinicaltrials.gov

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