NCT05464667

Brief Summary

The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
23mo left

Started Jul 2023

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2023Mar 2028

First Submitted

Initial submission to the registry

July 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

July 7, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Expected
Last Updated

December 12, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

July 11, 2022

Last Update Submit

December 5, 2025

Conditions

Breast Cancer

Keywords

Radiation Therapy (RT)

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD)

    Maximum tolerated dose (MTD) of RT, which will be defined based on the occurrence of grade 2 or higher acute radiation dermatitis as defined per National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE) v5.0, occurring within approximately 1 month after radiation therapy (RT). Dose escalation will begin with 30 GY and be escalated to 35, 40, and 50 GY as tolerated.

    Up to18 months (cohort)

Secondary Outcomes (9)

  • Acute Toxicities

    Up to 1 month

  • Late toxicities

    From 6 months, up to 24 months

  • Pathologic Complete Response (pCR)

    Up to 3 years

  • Quality of Life - EORTC QLQ BR23

    At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT

  • Breast Cancer Treatment Outcome Scale (BCTOS)

    At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT

  • +4 more secondary outcomes

Study Arms (1)

Radiation Therapy (RT)

EXPERIMENTAL

Preoperative Dose-escalated RT (4 Cohorts): Cohort 1: standard dose of 30 Gy in 5 fractions to the planning target volume (PTV) and 30 GY in 5 fractions to the gross target volume (GTV) Cohort 2: 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 35 Gy Cohort 3: 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 40 Gy Cohort 4: 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 50 Gy

Radiation: Radiation Therapy (RT)

Interventions

Radiation Therapy (RT)RADIATION

Dose Escalation: 4 Cohorts - 30 GY in 5 fractions (baseline treatment with 0 boost dose to GTV), 35, 40, 50 Gy in 5 fractions (Par 1) Dose Expansion: Maximum Tolerated Dose determined during dose escalation (Part 2)

Radiation Therapy (RT)

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatient must be biologically of female sex
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed diagnosis of breast cancer within 90 days from breast biopsy. NOTE: The day of biopsy is Day "0"
  • Patient biologically of the female sex
  • Must meet ALL the following criteria:
  • Age ≥ 50 years
  • Clinical size ≤ 3 cm (invasive) or ≤ 4 cm (DCIS) based on results of dedicated breast imaging.
  • All invasive subtypes and DCIS
  • ER positive, HER2/neu negative
  • No LVSI
  • Clinically negative lymph nodes based on results of dedicated breast imaging
  • The gross tumor should be \>1cm from the chest wall and the skin surface
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 within 90 days prior to registration
  • Patients of child-bearing age should have either a negative urine or serum pregnancy test within 14 days of study entry.
  • Patients of child-bearing age should be non-pregnant and non-lactating. They should use a medically acceptable form of contraception during RT.
  • Patients must have signed this study's informed consent prior to study entry.

You may not qualify if:

  • Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
  • Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix, melanoma in situ) unless disease free for a minimum of 5 years prior to study entry
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Two or more documented breast cancers within the index breast or bilateral breast cancer.
  • Suspicious unresected microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
  • Paget's disease of the nipple.
  • Male breast cancer.
  • Evidence of distant metastases.
  • Clinical regional lymph node involvement.
  • Prior RT to the region of the breast that would result in overlap of RT fields.
  • Intention to administer concurrent chemotherapy for current breast cancer.
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Magee Womens Hospital - Radiation Oncology

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Parul Barry, MD

    UPMC Hillman Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Demko, RN, BSN

CONTACT

412-623-1400albesl@upmc.edu

Brieana Marino, MS

CONTACT

412-647-8258rowlesbm@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor, Radiation Oncology

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 19, 2022

Study Start

July 7, 2023

Primary Completion

April 30, 2026

Study Completion (Estimated)

March 31, 2028

Last Updated

December 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)