Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer

Last updated: April 20, 2023
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ductal Carcinoma In Situ (Dcis)

Breast Cancer

Carcinoma

Treatment

N/A

Clinical Study ID

NCT04871516
Pro2020001306
042005
P30CA072720
NCI-2020-05711
Pro2020001306
  • Ages > 18
  • All Genders

Study Summary

This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Breast cancer patients with biopsy proven invasive cancer
  • Clinically and radiographically node negative
  • No indication of metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Synchronous bilateral invasive cancer allowed
  • Negative serum pregnancy test within one month from the radiation therapy (RT) boostdelivery
  • Willingness to participate in the clinical trial and adhere to the study protocol
  • Individuals of all races, genders and ethnic groups are eligible for this trial

Exclusion

Exclusion Criteria:

  • Need for neoadjuvant chemotherapy
  • Inflammatory breast cancer (cT4)
  • Multicentric tumor
  • Prior ipsilateral breast or thoracic RT
  • Contraindication for baseline magnetic resonance imaging (MRI)
  • Contraindication for surgery
  • Distant metastatic disease
  • Other synchronous cancer (besides bilateral breast)
  • Contraindication to radiation therapy (presence of scleroderma or other collagenvascular disease)
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator,may increase the risk associated with study participation or study drugadministration, impair the ability of the subject to receive protocol therapy, orinterfere with the interpretation of study results

Study Design

Total Participants: 55
Study Start date:
May 18, 2021
Estimated Completion Date:
January 31, 2024

Study Description

PRIMARY OBJECTIVE:

I. To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%).

SECONDARY OBJECTIVE:

I. To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI).

TERTIARY/EXPLORATORY OBJECTIVES:

I. To measure the acute and late radiation related toxicities such as radiation dermatitis, telangiectasia and fibrosis in this cohort of patients.

II. To measure the pre-operative boost clinical target volume (CTV) and compare to the post-op CTV volume that would have been contoured as CTV if the boost was to be delivered post-operatively.

III. To measure the incidence of fair/poor patient reported cosmetic outcome using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale.

IV. To study the cancer biology before and after radiation treatment.

OUTLINE:

Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, and 24 months

Connect with a study center

  • Clara Maass Medical Center

    Belleville, New Jersey 07109
    United States

    Active - Recruiting

  • RWJBarnabas Health-Trinitas Hospital and Comprehensive Care

    Elizabeth, New Jersey 07202
    United States

    Active - Recruiting

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey 08690
    United States

    Active - Recruiting

  • RWJBarnabas Health Jersey City Medical Center

    Jersey City, New Jersey 07302
    United States

    Active - Recruiting

  • RWJBarnabas Health - Monmouth Medical Center Southern Campus

    Lakewood, New Jersey 08701
    United States

    Active - Recruiting

  • Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • RWJBarnabas Health - Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Active - Recruiting

  • Rutgers New Jersey Medical School

    Newark, New Jersey 07101
    United States

    Site Not Available

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey 08876
    United States

    Active - Recruiting

  • RWJBarnabas Health - Community Medical Center

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.