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The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk 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: NCT02653755
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
NanoString Technologies, Inc.
Information provided by (Responsible Party):
Jennifer Bellon, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 10, 2016
First Posted Date  ICMJE January 12, 2016
Last Update Posted Date November 14, 2019
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2016)
Five-Year Risk of Local Regional Recurrence in the Ipsilateral Breast or Lymph Nodes in Women without Adjuvant Radiotherapy [ Time Frame: 5 years ]
Using information gathered from follow-up physical examinations and mammography, the 5-year risk of local regional recurrence in women who omit radiotherapy post-lumpectomy will be evaluated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2016)
  • Five-Year Risk of Any Recurrence: Local, Regional or Distant [ Time Frame: 5 years ]
    Using information gathered from follow-up physical examinations and mammography, the 5-year risk of any recurrence in women who omit radiotherapy post-lumpectomy will be evaluated.
  • Overall Survival [ Time Frame: 5 years ]
    Using information gathered from follow-up appointments and other record sources, 5-year survival rates will be evaluated.
  • Disease-Free Survival [ Time Frame: 5 years ]
    Using information gathered from follow-up physical exams, mammography and other imaging as necessary, the rate of disease-free status at 5 years will be evaluated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer
Official Title  ICMJE The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer
Brief Summary This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery". In this trial, we are attempting to identify which patients may not need radiation.
Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether it is appropriate for treating a specific disease.

The purpose of this study is to determine whether certain patients between the ages of 50 and 75 can safely omit radiation treatment after having a lumpectomy.In this research study, the investigators are using standard laboratory tests along with the Prosigna test to see if certain patients can avoid radiation, without having a higher risk of the cancer coming back in the future.

A portion of the participant surgical specimen will be prospectively maintained for future study using institutionally-approved tissue banking procedures.

The FDA (the U.S. Food and Drug Administration) has cleared the Prosigna test for generating a risk category and numerical score to assess the risk of distant recurrence, and has cleared us to investigate the use of the Prosigna test for helping with decisions about radiation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer Radiation
Intervention  ICMJE Device: Prosigna
Transcriptional profile of 50 genes used for risk stratification.
Other Name: PAM-50
Study Arms  ICMJE
  • Active Comparator: Ineligible for omission of RT
    Prosigna confirms intermediate- or high-risk score. Participants with intermediate- or high-risk scores will be ineligible for omission of radiotherapy (RT). Some patients with low-risk scores may elect to receive RT.
    Intervention: Device: Prosigna
  • Active Comparator: Eligible for omission of RT
    Prosigna confirms low risk score. Participant will be eligible for omission of therapy and chooses to do so. Patient will receive adjuvant endocrine therapy.
    Intervention: Device: Prosigna
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
690
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2016)
1380
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed invasive breast cancer
  • The primary tumor must be excised via breast conserving surgery ("lumpectomy") with negative margins ("no ink on tumor") or re-excision showing no residual disease in the re-excision specimen.
  • The tumor must be ≤2 cm (T1) in the largest dimension.
  • Immunohistochemical studies must demonstrate the tumor to be ER+ (≥10%) or PR+, HER2- and grade 1 or 2.
  • The patient must have undergone either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) demonstrating pathologic node-negativity (pN0). However, patients with immunohistochemical evidence of isolated tumor cells in a lymph node [pN0(i+)] are eligible if no deposit >0.2mm is identified.
  • Age: this study is open to patients between 50 and 75 years of age (inclusive). Patients younger than 50 years of age are excluded based on prior data suggesting a different natural history for breast cancers arising in premenopausal women (with different subtype and biologic distributions that may confound the current aims). Women older than 75 years of age are excluded from this protocol due to historical difficulties achieving robust follow-up in this population, along with competing comorbidities which have been shown to interfere with subsequent breast cancer monitoring and evaluation.
  • ECOG performance status ≤2 (Karnofsky ≥60%)
  • Life expectancy of >5 years per the clinical impression of the treating physician(s).
  • Eligible for and willing to undergo a course of adjuvant endocrine therapy.

Exclusion Criteria:

  • At the time of enrollment, subjects may not have had any prior systemic therapy for breast cancer, including chemotherapy, hormonal therapy or targeted biologic therapy. Similarly, chemotherapy or biologic therapy must not be part of the subsequent treatment plan.
  • Clinical, radiographic or pathologic evidence of multicentric disease.
  • Evidence of T4 disease (e.g., involvement of the chest wall, skin, dermal lymphatics, or inflammatory breast cancer).
  • Grade 3 histology.
  • Tumors in which the invasive component is present only as micro-invasion.
  • Multicentric invasive or in site carcinoma
  • Bilateral breast malignancy.
  • Inability or unwillingness to tolerate endocrine therapy.
  • Documented mutation of TP53, BRCA1, BRCA2, or other hereditary cancer syndromes.
  • Significant comorbidity associated with an estimation of <5 remaining life years.
  • Another diagnosis of malignancy within the 5 years preceding enrollment (excluding non-melanoma skin cancers or in situ cervical lesions, which are permitted).
  • Inability to understand or provide informed consent.
  • Current addictive or psychiatric disorder which may preclude protocol adherence.
  • Prior breast or chest radiotherapy for any indication.
  • Pregnant or lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giulia DiGiovanni, BS 617-582-8964 Giulia_DiGiovanni@DFCI.HARVARD.EDU
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653755
Other Study ID Numbers  ICMJE 15-255
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer Bellon, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE NanoString Technologies, Inc.
Investigators  ICMJE
Principal Investigator: Jennifer Bellon, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP