Eliminating Surgery After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer
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| ClinicalTrials.gov Identifier: NCT02945579 |
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Recruitment Status :
Recruiting
First Posted : October 26, 2016
Last Update Posted : July 24, 2019
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| 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 |
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 (immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified) or triple receptor negative (triple negative [TN], estrogen receptor [ER]/progesterone receptor [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
- 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
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 Kuerer | 713-745-5043 | hkuerer@mdanderson.org |
| United States, Arizona | |
| Banner Health/Banner Research | Not yet recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Stephanie C. Byrum 480-256-6444 stephanie.byrum@bannerhealth.com | |
| 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 beth.lesnikoski@hcahealthcare.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 clchong@queens.org | |
| Principal Investigator: Clayton D. Chong | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Judy C. Boughey 507-284-2511 boughey.judy@mayo.edu | |
| 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 diegoe@upmc.edu | |
| 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 hkuerer@mdanderson.org | |
| Principal Investigator: Henry M. Kuerer | |
| Principal Investigator: | Henry M Kuerer | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02945579 |
| Other Study ID Numbers: |
2016-0046 NCI-2016-01929 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2016-0046 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 26, 2016 Key Record Dates |
| Last Update Posted: | July 24, 2019 |
| Last Verified: | July 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma Breast Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |