NCT02295033

Brief Summary

Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase III trial is studying the effect of an extra dose of radiation therapy (Boost dose) after breast conserving surgery and 50 Gy adjuvant external beam radiotherapy to see how well it works compared to no further therapy in treating women with early breast cancer that has been surgically removed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1989

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

17 years

First QC Date

November 17, 2014

Last Update Submit

November 18, 2014

Conditions

Breast Cancer

Keywords

Boost versus no boost irradiation of early breast cancer

Outcome Measures

Primary Outcomes (1)

  • Time to local recurrence

    25 years from first patient in

Study Arms (2)

Boost irradiation

EXPERIMENTAL
Radiation: Boost irradiation

No boost irradiation

NO INTERVENTION

Interventions

Boost irradiationRADIATION
Boost irradiation

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented invasive adenocarcinoma (any subtype) of the breast with clinical stage T1-2 (0-5 cm) and pathologic stage N0-1, M0 disease
  • Lumpectomy with 1-2 cm margin required within 9 weeks of initiation of protocol radiotherapy
  • Axillary dissection required for premenopausal patients and recommended for postmenopausal patients (Irradiation of clinically negative axilla is an acceptable alternative to axillary dissection in postmenopausal patients)

You may not qualify if:

  • Residual microcalcification on postoperative mammogram
  • Gross residual disease in the breast (re-excision allowed if there is gross residual disease after first surgical procedure)
  • Multiple foci of tumor in more than 1 quadrant
  • Previous or concurrent malignant tumor in contralateral breast
  • In situ carcinoma of the breast, without invasive tumor
  • Tumorectomy performed more than 9 weeks before the start of radiotherapy in cases where no adjuvant chemotherapy is given and more than 6 months before the start of radiotherapy if chemotherapy is given
  • Previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • Concurrent pregnancy or lactation
  • Eastern Cooperative Oncology Group performance scale more than 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Vrieling C, van Werkhoven E, Maingon P, Poortmans P, Weltens C, Fourquet A, Schinagl D, Oei B, Rodenhuis CC, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan DA, Dubois JB, Remouchamps V, Mirimanoff RO, Hart G, Collette S, Collette L, Bartelink H; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Breast Cancer Groups. Prognostic Factors for Local Control in Breast Cancer After Long-term Follow-up in the EORTC Boost vs No Boost Trial: A Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):42-48. doi: 10.1001/jamaoncol.2016.3031.

    PMID: 27607734DERIVED

  • Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9.

    PMID: 25500422DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 19, 2014

Study Start

May 1, 1989

Primary Completion

May 1, 2006

Last Updated

November 19, 2014

Record last verified: 2014-11