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

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ClinicalTrials.gov Identifier: NCT04871516
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : February 14, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce G. Haffty, MD, Rutgers Cancer Institute of New Jersey

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Anatomic Stage 0 Breast Cancer AJCC v8 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 Invasive Breast Carcinoma Non-Metastatic Breast Carcinoma Prognostic Stage 0 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 Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Boost Procedure: Therapeutic Surgical Procedure Radiation: Whole Breast Irradiation Other: Breast MRI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients
Actual Study Start Date : May 18, 2021
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: For at least 36 months after WBI ]
    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.


Secondary Outcome Measures :
  1. Physician reported cosmesis [ Time Frame: At 1 month after whole breast irradiation (WBI) ]
    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).

  2. Physician reported cosmesis [ Time Frame: At 12 months after WBI ]
    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).

  3. Physician reported cosmesis [ Time Frame: At 36 months after WBI ]
    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.


Other Outcome Measures:
  1. Acute and late radiation toxicity [ Time Frame: Up to 24 months after WBI ]
    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.

  2. Patient reported cosmesis [ Time Frame: At 1 month after WBI ]
    Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS).

  3. Patient reported cosmesis [ Time Frame: At 12 months after WBI ]

    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.


  4. Patient reported cosmesis [ Time Frame: At 24 months after WBI ]

    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.


  5. Clinical target volume (CTV) [ Time Frame: Measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery ]
    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.

  6. Tumor histology and pathologic response [ Time Frame: Up to 24 months after WBI ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871516


Locations
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United States, New Jersey
The Cancer Institute of New Jersey Hamilton Not yet recruiting
Hamilton, New Jersey, United States, 08690
Contact: Rachana Singh    609-584-2801    rachana.singh4@rwjbh.org   
Principal Investigator: Rachana Singh         
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Bruce G. Haffty    732-253-5203    hafftybg@cinj.rutgers.edu   
Principal Investigator: Bruce G. Haffty         
Rutgers New Jersey Medical School Not yet recruiting
Newark, New Jersey, United States, 07101
Contact: Bruce G. Haffty    732-253-5203    hafftybg@cinj.rutgers.edu   
Principal Investigator: Bruce G. Haffty         
Robert Wood Johnson University Hospital Somerset Not yet recruiting
Somerville, New Jersey, United States, 08876
Contact: Laura R. Bond    908-268-5248    lbond@somerset-healthcare.com   
Principal Investigator: Laura R. Bond         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bruce G Haffty Rutgers Cancer Institute of New Jersey
More Information
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Responsible Party: Bruce G. Haffty, MD, Professor and Chairman, Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT04871516    
Other Study ID Numbers: Pro2020001306
NCI-2020-05711 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro2020001306
042005 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma in Situ