Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Dose-limiting toxicity (DLT)
Study Overview
Brief Summary
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.
Detailed Description
Breast cancer is the most common cancer diagnosis in females; with population ageing, this diagnosis may increase in 75 years old or older patients.
According to AIRTUM data, 22% of new cases of breast cancer and 14% of death by breast cancer are expected in women over 70 years old.
Surgery is the gold standard of treatment for breast cancer, but advanced age and age-related comorbidity could reduce the ability of a surgical approach.
In the United Kingdom, it is estimated that over 40% of older women will not receive surgical treatment for breast tumor, while endocrine therapy alone is frequently offered. This treatment is known as primary endocrine therapy.
In our country, AIOM guidelines favor endocrine therapy alone in women over 70 with ER-positive tumors instead of surgical resection, even emphasizing the importance of local treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Dose-limiting toxicity (DLT)
Time Frame: 6 months
DLT is determined as any grade 3 or worse toxicity (per CTCAE v5.0) that occurs within 6 months from the start of SBRT
Secondary Outcomes
- Progression-free survival (PFS)(5 years)
- Cosmesis assesed by Harvard scale(5 years)
- Locoregional disease control (LRC)(5 years)
- patient reported therapy side effects assesed by EORTC QLQ-BR23(5 years)
- Clinical complete response (cCR)(6 months)
- patient reported global health status assesed by EORTC QLC-C30(5 years)
- Cosmesis assesed by BREAST-Q v2.0(5 years)
- Overall survival (OS)(5 years)
Investigators
Laura Cedrone
Resident
University of Rome Tor Vergata