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BoMB: Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

Sponsor
Campus Bio-Medico University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05229575
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
33
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT) in treating breast primary tumor in metastatic breast cancer are:

  • radio-biological advantage of a short highly effective treatment schedule

  • possibility of preventing lesions to become symptomatic

  • possibility of continuing systemic treatment without interruption

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
Actual Study Start Date :
Jul 10, 2020
Anticipated Primary Completion Date :
Oct 10, 2022
Anticipated Study Completion Date :
Apr 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stereotactic Body Radiation Therapy (SBRT)

Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks

Radiation: Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose of stereotactic body radiotherapy (SBRT) [6 months]

    the dose of radiotherapy associated with a ≤ 20% rate pre-specified treatment-related dose -limiting toxicity (DLT) occurring within 6 months from the start of treatment. DLT is defined as any grade 3 or worse toxicity according to CTCAE v.4 related to the following specific symptoms: Radiation dermatitis grade > 3 Breast pain grade 3 Breast infection grade > 3 Breast asymmetry grade 3 Fibrosis grade > 3 Skin atrophy grade 3 Rib fracture grade 3 Chest wall pain grade 3

Secondary Outcome Measures

  1. Rate of long-term adverse events [2 years]

    scored according to the NCI CTCAE v. 4.2

  2. Breast Cosmesis [2 years]

    scored according to the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer for the evaluation of cosmetics (score 1 to 4, no difference-large difference by comparing the treated breast to the controlateral breast) and carried out separately by the doctor and the patient

  3. QoL [2 years]

    scored according to the EORTC quality of life questionnaire (QLQ) in breast cancer patients (EORTC QLQ-C30 / BR23)

  4. Primary breast tumor best response [2 years]

    evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1)

Other Outcome Measures

  1. Primary breast tumor local failure [2 years]

    2 years local failure probability of treated primary tumor predicted by CT planning images

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age: 18 years or older

  • Histologically confirmed diagnosis of invasive breast carcinoma (biological immunohistochemical profile: luminal and/or human epidermal growth factor receptor 2 positive)

  • Distant metastatic disease not progressing after 6 months of systemic therapy

  • Zubrod Performance status of 0-1

  • Unifocal tumour < 5 cm tumor size

  • Tumor CT or 18-labeled fluorodeoxyglucose positron emission tomography (5FDG-PET) detectable

  • No surgery being recommended at time of enrollment.

Exclusion Criteria:

  • prior radiotherapy

  • active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash

  • Women who are pregnant or lactating.

  • Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol

Contacts and Locations

Locations

Site City State Country Postal Code
1 Università Campus Biomedico Roma Italy

Sponsors and Collaborators

  • Campus Bio-Medico University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT05229575
Other Study ID Numbers:
  • 46.20 PAR ComEt CBM
First Posted:
Feb 8, 2022
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 8, 2022