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

ConditionsEstrogen Receptor NegativeHER2 Positive Breast CarcinomaHER2/Neu NegativeInvasive Breast CarcinomaProgesterone Receptor NegativeStage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Triple-Negative Breast Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort A1 and A2

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Undergo EBRT

    Radiation

    Undergo EBRT

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Partial Breast Irradiation

    Radiation

    Undergo partial breast irradiation

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Cohort AExperimental treatment 4 interventions
Group B: Cohort BExperimental treatment 5 interventions
Group C: Cohort CExperimental treatment 3 interventions
Group D: Cohort DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ipsilateral breast tumor recurrence-free survival (IBT-RFS)

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.

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 10 years
2

Overall survival

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.

Time frame
Up to 10 years

Secondary outcomes

Other outcomes

1

Change in biomarkers in blood and plasma

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.

Time frame
3 months, 3-8 weeks post radiation therapy (if applicable), 6 months, 12 months]
2

Residual cancer burden (RCB)

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.

Time frame
Up to 10 years
3

Incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up

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.

Time frame
Up to 10 years
4

Quality of Life measured by DRS questionnaire

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

Time frame
Baseline, 6 months, 12 months, 36 months, 60 months, 84 months, and 120 months]

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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