NCT03359954

Brief Summary

This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
18mo left

Started Nov 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not 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 Progress85%
Nov 2017Oct 2027

Study Start

First participant enrolled

November 16, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

November 28, 2017

Last Update Submit

March 3, 2026

Conditions

Estrogen Receptor PositiveHER2/Neu NegativeInvasive Breast CarcinomaProgesterone Receptor Positive

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)

    With 20 patients, a 95% confidence interval for the mean difference between TIL measurements would extend 0.44\*s units from the mean (where "s" is the standard deviation of the TIL differences). If the differences are not normally distributed, researchers will report the median difference along with appropriate 95% confidence intervals. Appropriate graphs used to visualize the data.

    6 to 8 days after preoperative radiotherapy

Secondary Outcomes (4)

  • Delay Rate of Surgery Following Boost RT

    4 weeks after boost RT

  • Tumor Changes between pre and post boost

    Up to 4 weeks after surgery

  • Toxicity calculated using the CTCAE v4.0

    6 months after adjuvant RT

  • Changes in dynamic contrast enhanced (DCE)

    4 weeks after surgery

Study Arms (1)

Treatment (radiation therapy, surgery)

EXPERIMENTAL

Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

Radiation: Radiation TherapyProcedure: Therapeutic Conventional Surgery

Interventions

Radiation TherapyRADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation
Treatment (radiation therapy, surgery)
Therapeutic Conventional SurgeryPROCEDURE

Undergo breast surgery

Treatment (radiation therapy, surgery)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>/=18 years at time of study entry
  • Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
  • Presence of a clip in the primary breast cancer
  • Biopsy-amenable residual disease in the breast measuring \>/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Signed written informed consent
  • Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon.

You may not qualify if:

  • Women who are pregnant or breast-feeding
  • Contraindication to receive radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

RadiotherapyRadiation

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Phenomena

Study Officials

  • Simona F Shaitelman

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 2, 2017

Study Start

November 16, 2017

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)