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

A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage 0 Breast Cancer AJCC v8; Prognostic Stage 0 Breast Cancer AJCC v8; Invasive Breast Carcinoma; Non-Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Boost; Procedure: Therapeutic Surgical Procedure; Radiation: Whole Breast Irradiation; Other: Breast MRI

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Recruiting
      • Clara Maass Medical Center
      • Contact: Bruce Haffty, MD; Phone Number: 732-235-5203; Email: haffty@cinj.rutgers.edu
    • Elizabeth, New Jersey, United States, 07202
      • Recruiting
      • RWJBarnabas Health-Trinitas Hospital and Comprehensive Care
      • Contact: Bruce Haffty, MD; Phone Number: 732-235-5203; Email: haffty@cinj.rutgers.edu
    • Hamilton, New Jersey, United States, 08690
      • Recruiting
      • The Cancer Institute of New Jersey Hamilton
      • Contact: Rachana Singh; Phone Number: 609-584-2801; Email: rachana.singh4@rwjbh.org
      • Principal Investigator: Rachana Singh
    • Jersey City, New Jersey, United States, 07302
      • Recruiting
      • RWJBarnabas Health Jersey City Medical Center
      • Contact: Bruce Haffty, MD; Phone Number: 732-235-5203; Email: haffty@cinj.rutgers.edu
    • Lakewood, New Jersey, United States, 08701
      • Recruiting
      • RWJBarnabas Health - Monmouth Medical Center Southern Campus
      • Contact: Bruce Haffty, MD; Phone Number: 732-235-5203; Email: haffty@cinj.rutgers.edu
    • Livingston, New Jersey, United States, 07039
      • Recruiting
      • Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
      • Contact: Bruce Haffty, MD; Phone Number: 732-235-5203; Email: haffty@cinj.rutgers.edu
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Bruce G. Haffty; Phone Number: 732-253-5203; Email: hafftybg@cinj.rutgers.edu
    • Newark, New Jersey, United States, 07112
      • Recruiting
      • RWJBarnabas Health - Newark Beth Israel Medical Center
      • Contact: Bruce Haffty, MD; Phone Number: 732-235-5203; Email: haffty@cinj.rutgers.edu
    • Newark, New Jersey, United States, 07101
      • Not yet recruiting
      • Rutgers New Jersey Medical School
      • Contact: Bruce G. Haffty; Phone Number: 732-253-5203; Email: hafftybg@cinj.rutgers.edu
    • Somerville, New Jersey, United States, 08876
      • Recruiting
      • Robert Wood Johnson University Hospital Somerset
      • Contact: Laura R. Bond; Phone Number: 908-268-5248; Email: lbond@somerset-healthcare.com
      • Principal Investigator: Laura R. Bond
    • Toms River, New Jersey, United States, 08755
      • Recruiting
      • RWJBarnabas Health - Community Medical Center
      • Contact: Bruce Haffty, MD; Phone Number: 732-235-5203; Email: hafftybg@cinj.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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) boost delivery
• 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 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 collagen vascular disease)
• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (radiation therapy boost, WBI); 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Radiation: Radiation Boost; Undergo radiation therapy boost; Other Names: Boost Radiation; Boost Radiation Therapy; Boost Radiotherapy; Radiation Therapy Boost; Radiotherapy Boost; Procedure: Therapeutic Surgical Procedure; Undergo standard surgery; Radiation: Whole Breast Irradiation; Undergo standard WBI; Other: Breast MRI; A baseline breast MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.	Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.	For at least 36 months after WBI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician reported cosmesis	Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor).	At 1 month after whole breast irradiation (WBI)
Physician reported cosmesis	Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor).	At 12 months after WBI
Physician reported cosmesis	Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor). Will be reported as a proportion; CI will be calculated using the Clopper-Pearson model.	At 36 months after WBI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and late radiation toxicity	Rate of fibrosis, rate of telangiectasia formation and rate of radiation dermatitis will be assessed by the radiation oncologist using descriptions and grading scales found in the NCI CTCAE v5.0. Will also assess changes in pathology between the biopsy and the surgical specimen.	Up to 24 months after WBI
Patient reported cosmesis	Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS).	At 1 month after WBI
Patient reported cosmesis	Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS). Breast Cancer Treatment Outcome Scale is a questionnaire designed to assess women's subjective evaluation of both the aesthetic and functional outcome after breast cancer treatment. Patients are instructed to rate each item of the BCTOS questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference to 4 = large difference). Higher scores reflect worse outcomes.	At 12 months after WBI
Patient reported cosmesis	Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS). Breast Cancer Treatment Outcome Scale is a questionnaire designed to assess women's subjective evaluation of both the aesthetic and functional outcome after breast cancer treatment. Patients are instructed to rate each item of the BCTOS questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference to 4 = large difference). Higher scores reflect worse outcomes.	At 24 months after WBI
Clinical target volume (CTV)	The difference between the pre-operative boost Clinical target volume (CTV) and the post-op Clinical target volume (CTV) volume that would have been contoured as Clinical target volume (CTV) if the boost was to be delivered post-operatively.	Measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery
Tumor histology and pathologic response	Another goal is to look into the histopathology of tumors before and after radiation to assess response and other immunologic changes to the tumor and the tumor environment elicited by the radiation treatment.	Up to 24 months after WBI

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bruce G Haffty, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Breast Carcinoma In Situ
• Other Study ID Numbers: Pro2020001306; P30CA072720 (U.S. NIH Grant/Contract); NCI-2020-05711 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 042005 (Other Identifier: Rutgers Cancer Institute of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes