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

NCT02653755 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 15-255
• Study Type: interventional
• Target: 671
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer Radiation

Keywords

Breast Cancer Radiation; Radiotherapy for Favorable-Risk Breast cancer; Radiotherapy Omission

Outcome Measures

Primary Outcomes (1)

• Five-Year Risk of Local Regional Recurrence in the Ipsilateral Breast or Lymph Nodes in Women without Adjuvant Radiotherapy

  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.

  5 years

Secondary Outcomes (3)

• Five-Year Risk of Any Recurrence: Local, Regional or Distant

  5 years

• Overall Survival

  5 years

• Disease-Free Survival

  5 years

Study Arms (2)

Ineligible for omission of RT

ACTIVE COMPARATOR

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.

Device: Prosigna

Eligible for omission of RT

ACTIVE COMPARATOR

Prosigna confirms low risk score. Participant will be eligible for omission of therapy and chooses to do so. Patient will receive adjuvant endocrine therapy.

Device: Prosigna

Interventions

Prosigna DEVICE

Transcriptional profile of 50 genes used for risk stratification.

Also known as: PAM-50

Eligible for omission of RT; Ineligible for omission of RT

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• NanoString Technologies, Inc.: collaborator

Study Sites (6)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Memorial Sloane Kettering Cancer Center

New York, New York, 10065, United States

Location

Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Ho AY, Bellon JR. Overcoming Resistance - Omission of Radiotherapy for Low-Risk Breast Cancer. N Engl J Med. 2023 Feb 16;388(7):652-653. doi: 10.1056/NEJMe2216133. No abstract available.

  PMID: 36791166 DERIVED

Study Officials

• Julia Wong, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2016
• First Posted: January 12, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)