Partial Breast Versus no Irradiation for Women With Early Breast Cancer

NCT03646955 | Recruiting DMC

• 1 other identifier: DBCG RT Natural Trial
• Study Type: interventional
• Target: 926
• Locations: 4 countries
• Sites: 17

Brief Summary

All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.

Conditions

Local Neoplasm Recurrence; Distantly Metastatic Malignant Neoplasm; Death; Fibrosis Breast; Depigmentation/Hyperpigmentation of Skin; Telangiectasia; Scar; Pain; PROMs

Outcome Measures

Primary Outcomes (1)

• Invasive local recurrence

  Invasive local recurrence

  10 years

Secondary Outcomes (3)

• Regional nodes recurrence

  10 years

• Distant failure

  10 years

• Death

  10 years

Study Arms (2)

Partial breast irradiation

ACTIVE COMPARATOR

External beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks

Radiation: No partial breast irradiation

No partial breast irradiation

NO INTERVENTION

No radiation therapy

Interventions

No partial breast irradiation RADIATION

Omission of radiation therapy

Partial breast irradiation

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient \>=60 years
• Primary tumour characteristics by conventional histopathology
• unilateral and unifocal non-lobular histology grade 1-2
• maximum microscopic size \<=20mm
• node negative determined by sentinel node or axillary lymph node dissection
• estrogen receptor \>=10% positive
• HER2 negative (by IHC and/or in situ hybridization)
• resection margin \>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer
• Surgical type is breast conservation
• Performance status ECOG 0-2
• No evidence of distant metastasis

You may not qualify if:

• multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
• evidence of clinical or pathological T4 breast cancer
• grade 3 malignancy
• previous breast cancer or DCIS irrespective of disease-free interval
• previous radiation therapy to the breast or thorax,
• previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
• comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
• mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
• documented hereditary breast cancer or with high genetic risk of breast cancer
• life expectancy \<10 years

Sponsors & Collaborators

• Danish Breast Cancer Cooperative Group: lead
• Danish Cancer Society: collaborator
• Danish Center for Interventional Research in Radiation Oncology (CIRRO): collaborator

Study Sites (17)

Ponticia Universidad Catolica de Chile

Santiago, Chile

RECRUITING

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Naestved Hospital

Næstved, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Vejle Hospital

Vejle, Denmark

RECRUITING

Haukeland HUS

Bergen, Norway

RECRUITING

Nordlandssykehuset

Bodø, Norway

RECRUITING

Kristiansand Hospital

Kristiansand, Norway

RECRUITING

Oslo University Hospital, Radiumhospitalet

Oslo, Norway

RECRUITING

Stavanger Hospital

Stavanger, Norway

RECRUITING

Tromsø University Hospital

Tromsø, Norway

RECRUITING

Sahlgrenska University hospital

Gothenburg, Sweden

RECRUITING

Skånes University Hospital

Lund, Sweden

RECRUITING

Uppsala Akademiska Sjukhuset

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Neoplasm Recurrence, Local; Death; Vitiligo; Hyperpigmentation; Telangiectasis; Cicatrix; Pain

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Fibrosis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Birgitte V Offersen, PhD

  Danish Breast Cancer Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitte V Offersen, PhD

CONTACT

+45 28838012; bvo@oncology.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, MD

Model Details: Clinically controlled randomized trial

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: August 24, 2018
• Study Start: September 5, 2018
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2035
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: It will only be possible if the DBCG Radiation Therapy Committee decides that it is acceptable
• Access Criteria: The DBCG Radiation Therapy Committee will define the criteria after publication of the results from the trial

Locations

SE (3); CL (1); NO (6); DK (7)