Clinical trial NCT02653755: 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: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Radiation
Keywords: Breast Cancer Radiation
Radiotherapy for Favorable-Risk Breast cancer
Radiotherapy Omission
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: NanoString Technologies, Inc.
First posted: 2016-01-12
Enrollment: 671
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Five-Year Risk of Local Regional Recurrence in the Ipsilateral Breast or Lymph Nodes in Women without Adjuvant Radiotherapy
timeFrame: 5 years
Secondary outcomes:
measure: Five-Year Risk of Any Recurrence: Local, Regional or Distant
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
measure: Disease-Free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Memorial Sloane Kettering Cancer Center
state: New York
city: Providence
country: United States
facility: Lifespan Cancer Institute
state: Rhode Island
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Julia Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: