Clinical trial · Interventional
SBRT in Early Breast Cancer in Elderly Women
Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy. In Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor. In recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery. Stereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting. Against this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 40Gy/5fx
- description
- The starting dose level will be 8Gy x 5 fractions, i.e., 40 Gy/5 nonconsecutive once-daily fractions.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- 42.5Gy/5fx
- description
- The intermediate dose level will be 8.5Gy x 5 fractions, i.e. 42.5Gy/5 nonconsecutive once-daily fractions.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- 45Gy/5fx
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 75 years * Histologically confirmed diagnosis of local disease only (cT1-T2 N0 M0) * Luminal like A or B (estrogen receptor positive and/or progesterone receptor positive and Her2 negative Tumors) * SBRT within 2 months after hormonal therapy start Exclusion Criteria: * Metastatic Disease * Evidence of loco-regional nodal disease * Multifocal or multicentric tumors * Prior radiotherapy to the region of the study cancer that would result in overlap of therapy fields * Concurrent systemic disorders that contraindicate radiotherapy
References
Publications (25)
- RESULTHind D, Wyld L, Beverley CB, Reed MW. Surgery versus primary endocrine therapy for operable primary breast cancer in elderly women (70 years plus). Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004272. doi: 10.1002/14651858.CD004272.pub2. PMID 16437480
- RESULTKinoshita T, Iwamoto E, Tsuda H, Seki K. Radiofrequency ablation as local therapy for early breast carcinomas. Breast Cancer. 2011 Jan;18(1):10-7. doi: 10.1007/s12282-009-0186-9. Epub 2010 Jan 14. PMID 20072824
- RESULTSchmitz AC, Gianfelice D, Daniel BL, Mali WP, van den Bosch MA. Image-guided focused ultrasound ablation of breast cancer: current status, challenges, and future directions. Eur Radiol. 2008 Jul;18(7):1431-41. doi: 10.1007/s00330-008-0906-0. Epub 2008 Mar 20. PMID 18351348
- RESULTCourdi A, Ortholan C, Hannoun-Levi JM, Ferrero JM, Largillier R, Balu-Maestro C, Chapellier C, Ettore F, Birtwisle-Peyrottes I. Long-term results of hypofractionated radiotherapy and hormonal therapy without surgery for breast cancer in elderly patients. Radiother Oncol. 2006 May;79(2):156-61. doi: 10.1016/j.radonc.2006.04.005. Epub 2006 May 15. PMID 16698099
- RESULTArriagada R, Mouriesse H, Rezvani A, Sarrazin D, Clark RM, DeBoer G, Bush RS. Radiotherapy alone in breast cancer. Analysis of tumor and lymph node radiation doses and treatment-related complications. The experience of the Gustave-Roussy Institute and the Princess Margaret Hospital. Radiother Oncol. 1993 Apr;27(1):1-6. doi: 10.1016/0167-8140(93)90037-9. PMID 8327727
- RESULTVan Limbergen E, Van der Schueren E, Van den Bogaert W, Van Wing J. Local control of operable breast cancer after radiotherapy alone. Eur J Cancer. 1990;26(6):674-9. doi: 10.1016/0277-5379(90)90115-a. PMID 2168190
- RESULTVan Limbergen E, Rijnders A, van der Schueren E, Lerut T, Christiaens R. Cosmetic evaluation of breast conserving treatment for mammary cancer. 2. A quantitative analysis of the influence of radiation dose, fractionation schedules and surgical treatment techniques on cosmetic results. Radiother Oncol. 1989 Dec;16(4):253-67. doi: 10.1016/0167-8140(89)90037-6.