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Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer

Phase 2
50 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer

Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as
Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive
breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local
recurrences, in particular regarding the local recurrences, the toxicity and for the
cosmetic result.

Inclusion Criteria

Inclusion criteria

- Stage 0, I or II breast cancer.

- Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.

- Ductal carcinoma in situ (DCIS) alone.

- No lymph invasion (L0) and no hemangiosis (V0).

- Lesions of < 3 cm diameter, histopathologically assured.

- pN0 (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable).

- M0.

- Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS
histology only the resection margins must be clear at least 5 mm.

- For DCIS only: lesions must be classified as low or intermediate risk group

- Unifocal and unicentric DCIS or breast cancer.

- Age > 50 years.

- Time interval from final definitive breast surgical procedure to the start of
external beam therapy or to brachytherapy is less than 12 weeks (84 days). If
patients receive chemotherapy the radiotherapy can be started before systemic
treatment (within 12 weeks). The radiation therapy can be also given in the interval
between the chemotherapy courses. It is also possible to start radiation therapy
after chemotherapy is completed according local protocols as soon as possible within
4 weeks after chemotherapy.

- Signed study-specific consent form

Exclusion Criteria:

- Stage III or IV breast cancer.

- Surgical margins that cannot be microscopically assessed.

- Extensive intraductal component (EIC).

- Paget's disease or pathological skin involvement.

- Synchronous or previous breast cancer.

- Prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin
cancer or cervical carcinoma International Federation of Gynecology and Obstetrics
(FIGO) 0 and I if patient is continuously disease-free.

- Pregnant or lactating women.

- Collagen vascular disease.

- The presence of congenital diseases with increased radiation sensitivity, for example
Ataxia telangiectatic or similar.

- Psychiatric disorders.

- Patient with breast deemed technically unsatisfactory for brachytherapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

local control rates

Outcome Time Frame:

five years

Safety Issue:


Principal Investigator

Vratislav Strnad, MD, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Erlangen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2010

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • Brachytherapy
  • APBI
  • dose modification
  • local recurrences
  • side effects
  • cosmetic result
  • Breast Neoplasms