Eliminating Surgery After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02945579|
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female||Procedure: Breast Biopsy Radiation: Radiation Therapy Behavioral: Questionnaire||Not Applicable|
I. To determine the 6 months (mo), 1, 2, 3, and 5-year biopsy confirmed ipsilateral breast tumor recurrence rate (IBTR, invasive, and/or in situ) among patients who do not undergo surgery.
I. To determine the number (%) of patients where final biopsy reveals residual disease and quantify the residual disease (residual cancer burden, RCB) determined by routine pathologic examination of surgery specimens.
II. To assess baseline, 6 months, 1, 3, and 5 years decisional comfort of clinical trial participation using the Decisional Regret Scale (DRS).
III. To determine patient-reported cosmetic outcome, breast pain, and functional status using the Breast Cancer Treatment Outcomes Scale (BCTOS) at baseline, 6 months, 1, 3, and 5 years.
IV. To determine the 6 mo, 1, 2, 3, and 5-year incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up.
V. Correlate "liquid biopsy" analyses (after neoadjuvant systemic therapy [NST], 6 months and one year postradiotherapy or surgery) among protocol participants with pathologic complete response (pCR), utilizing circulating tumor cells (CTCs) and circulating tumor-deoxyribonucleic acid (DNA) (ctDNA).
VI. Among patients who decide to proceed with routine surgery, record the results of final biopsy compared with routine pathologic examination of surgery specimens.
VII. To determine patient-reported quality of life using the Functional Assessment of Cancer Therapy-Breast version 4 (FACT B+4) instrument at baseline, 6 months, 1, 3, and 5 years after treatment.
Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo external beam radiation therapy (EBRT) boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.
After completion of study treatment, patients are followed up every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy|
|Actual Study Start Date :||January 20, 2017|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Breast Cancer Surveillance
Feasibility Phase to enroll 6 participants then Expansion Phase begins.
Image-guided biopsy of the breast performed after completing chemotherapy and before beginning radiation therapy.
Radiation therapy to the breast performed within 12 weeks after completion of chemotherapy.
Questionnaires completed at baseline and again at 6 months, 1, 3, and 5 years after post-chemotherapy biopsy.
Procedure: Breast Biopsy
Participant undergoes an image-guided biopsy of the breast to test for evidence of disease at any point after completing chemotherapy and before beginning radiation therapy.
Radiation: Radiation Therapy
Radiation therapy to the breast performed within 12 weeks after completion of chemotherapy. The dose amount and length of the radiation therapy period decided by treating physician.
Questionnaires about quality of life and symptoms completed at baseline and again at 6 months, 1, 3, and 5 years after post-chemotherapy biopsy.
Other Name: Surveys
- Feasibility of Treatment Regimen [ Time Frame: 6 months after radiation therapy ]If none of the first 6 patients with pathologic complete response (pCR) are to experience an ipsilateral breast tumor recurrence (IBTR) during their first 6 months after they obtain a pCR, proposed treatment regimen is feasible.
- Ipsilateral Breast Tumor Recurrence-Free Survival (IBT-RFS) [ Time Frame: 5 years ]
Ipsilateral breast tumor recurrence-free survival (IBT-RFS) defined as the time from confirmation of pCR to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact.
IBT-RFS monitored using the method of Thall et al.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945579
|Contact: Henry Kuererfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Henry M. Kuerer 713-745-5043 email@example.com|
|Principal Investigator: Henry M. Kuerer|
|Principal Investigator:||Henry Kuerer||M.D. Anderson Cancer Center|