Whole Breast Irradiation vs Twice Daily vs. Once Daily Accelerated Partial Breast Irradiation

National Cancer Institute, Egypt

Status

Unknown

Conditions

Breast Cancer

Radiation Toxicity

Treatments

Radiation: Twice Daily APBI

Radiation: Once Daily APBI

Radiation: Whole Breast Irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT03616626

NCI-BC-12/2012

Details and patient eligibility

About

This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray (Gy) in 25 daily fractions over 5 weeks or Accelerated Partial Breast Irradiation (APBI) 38.5 Gy in 10 daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Full description

Women with invasive carcinoma of the breast less than 3 cm with negative axillary nodes , following BCS, who meet the inclusion criteria will be approached for potential study enrollment.

Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3DCRT WBI 50 Gy in 25 fractions over 5 weeks or APBI 38.5 Gy in 10 once daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85 Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists using the EORTC Breast Cosmetic Rating System. Radiation toxicity will be assessed using the NCI CTCAE version 4.0. The primary outcome is to compare the acute, late toxicities and adverse cosmetic outcomes at 6, 12 and 18 months among the three groups.

Enrollment

91 patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Tumor characteristics

Histologically confirmed invasive adenocarcinoma of the breast
Tumors must be ≤ 3 cm. Gross disease must be unifocal. Negative lymph nodes
Hormone receptor status:

Estrogen receptor (ER) status known Progesterone status known if ER analysis is negative Marginal or borderline results are considered positive Surgery

Tumor removed with conservative breast surgery with adequate margin
Re-excision of surgical margins allowed
No prior breast implants
Prior axillary staging required for patients including 1 of the following:
- Sentinel node biopsy alone (if sentinel node is negative)
- Sentinel node biopsy followed by axillary dissection if sentinel node is positive)
- Axillary dissection alone with ≥ 6 axillary nodes
Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
No prior biologic therapy for this malignancy Chemotherapy
No prior chemotherapy for this malignancy
No concurrent chemotherapy during study radiotherapy Endocrine therapy
No prior hormonal therapy for this malignancy
Concurrent hormonal therapy allowed provided it is not administered during chemotherapy
No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs
No concurrent hormone replacement therapy Radiotherapy
No prior radiotherapy for this malignancy
No prior breast or thoracic radiotherapy
No concurrent regional nodal irradiation Other
No other concurrent anticancer therapy Menopausal status
Premenopausal or postmenopausal Performance status
WHO 0-1 Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective non-hormonal contraception

Exclusion criteria

Multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm.
Non-epithelial breast malignancies (e.g., sarcoma or lymphoma).
Positive axillary nodes.
Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
Paget's disease of the nipple
Previous history of invasive breast cancer or DCIS.
Synchronous bilateral invasive or non-invasive breast cancer
Collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a CPK level above normal, or active skin rash
Psychiatric or addictive disorder that would preclude study therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

91 participants in 3 patient groups

Whole Breast Irradiation

Active Comparator group

Description:

Adjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years

Treatment:

Radiation: Whole Breast Irradiation

Once Daily APBI

Experimental group

Description:

Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks

Treatment:

Radiation: Once Daily APBI

Twice Daily APBI

Experimental group

Description:

Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week