Eliminating Surgery After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02945579|
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Radiation: External Beam Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Whole Breast Irradiation||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: Treatment (whole breast irradiation, EBRT)
Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo EBRT boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.
Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Radiation: Whole Breast Irradiation
Undergo whole breast irradiation
- Ipsilateral breast tumor recurrence-free survival (IBT-RFS) [ Time Frame: From confirmation of pathologic complete response (pCR) to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact, assessed for up to 5 years ]Will monitor IBT-RFS using the method of Thall et al. Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
- Overall survival [ Time Frame: Up to 5 years ]Will be estimated using the Kaplan-Meier method log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
- Change in biomarkers in blood and plasma [ Time Frame: Baseline, 6 months, 12 months ]Biomarkers in blood and plasma, specifically CTC and cDNA, will be assessed by exploratory data analysis and graphical methods, which will be applied to examine distributions and to identify data errors and outliers. Linear mixed effect models for repeated measures analysis will be employed to assess the change of the data over time with multi-covariates including disease characteristics (tumor stage, site, pathology), and other patient prognostic factors.
- Quality of Life measured by FACT-B+4 questionnaire [ Time Frame: Baseline, 6 months, 12 months, 36 months, 60 months ]The FACT-B+4 will assess the general quality of life of the patient.
- Quality of Life measured by BCTOS questionnaire [ Time Frame: Baseline, 6 months, 12 months, 36 months, 60 months ]The Breast Cancer Treatment Outcome Scale (BCTOS) will assess patient-reported cosmetic outcome, breast pain, and functional status by comparing the affected breast with her unaffected breast.
- Quality of Life measured by DRS questionnaire [ Time Frame: Baseline, 6 months, 12 months, 36 months, 60 months ]
The Decisional Regret Scale (DRS) questionnaire will assess the decisional comfort of the clinical trial participant.
Question answers range : Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, or Strongly Agree
- Incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up [ Time Frame: Up to 5 years ]Multivariable logistic regression analysis using generalized estimating equations to take the intra-patient correlation into account will be used to determine factors significantly associated with the outcome.
- Residual cancer burden (RCB) [ Time Frame: Up to 5 years ]Will be assessed by biopsy and routine surgery. Descriptive statistics will be used. The final biopsy will be compared with the response status determined by routine pathologic examination of surgery specimens using McNemar test.
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 Kuereremail@example.com|
|United States, Arizona|
|Banner Health/Banner Research||Not yet recruiting|
|Phoenix, Arizona, United States, 85006|
|Contact: Stephanie C. Byrum 480-256-6444 firstname.lastname@example.org|
|Principal Investigator: Stephanie C. Byrum|
|United States, Florida|
|Baptist MD Anderson Cancer Center||Not yet recruiting|
|Jacksonville, Florida, United States, 32207|
|Contact: Beth A. Lesnikoski email@example.com|
|Principal Investigator: Beth A. Lesnikoski|
|United States, Hawaii|
|Queen's Medical Center||Recruiting|
|Honolulu, Hawaii, United States, 96813|
|Contact: Clayton D. Chong 808-691-8777 firstname.lastname@example.org|
|Principal Investigator: Clayton D. Chong|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Judy C. Boughey 507-284-2511 email@example.com|
|Principal Investigator: Judy C. Boughey|
|United States, New Jersey|
|MD Anderson Cancer Center at Cooper-Voorhees||Recruiting|
|Voorhees, New Jersey, United States, 08043|
|Contact: Catherine E. Loveland-Jones 856-135-6207 loveland-jones-catherine@CooperHealth.edu|
|Principal Investigator: Catherine E. Loveland-Jones|
|United States, North Carolina|
|Carolinas Medical Center/Levine Cancer Institute||Recruiting|
|Charlotte, North Carolina, United States, 28203|
|Contact: Richard L. White 980-442-6358 Richard.White@atriumhealth.org|
|Principal Investigator: Richard L. White|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Emilia J. Diego 412-641-3083 firstname.lastname@example.org|
|Principal Investigator: Emilia J. Diego|
|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 M Kuerer||M.D. Anderson Cancer Center|