SBRT in Early Breast Cancer in Elderly Women

NCT05071105 | Recruiting DMC

• 1 other identifier: 222.20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female

Keywords

Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  DLT is determined as any grade 3 or worse toxicity (per CTCAE v5.0) that occurs within 6 months from the start of SBRT

  6 months

Secondary Outcomes (8)

• Locoregional disease control (LRC)

  5 years

• Clinical complete response (cCR)

  6 months

• Cosmesis assesed by Harvard scale

  5 years

• Cosmesis assesed by BREAST-Q v2.0

  5 years

• Progression-free survival (PFS)

  5 years

Study Arms (3)

40Gy/5fx

EXPERIMENTAL

The starting dose level will be 8Gy x 5 fractions, i.e., 40 Gy/5 nonconsecutive once-daily fractions.

Radiation: Stereotactic Body Radiation Therapy

42.5Gy/5fx

EXPERIMENTAL

The intermediate dose level will be 8.5Gy x 5 fractions, i.e. 42.5Gy/5 nonconsecutive once-daily fractions.

Radiation: Stereotactic Body Radiation Therapy

45Gy/5fx

EXPERIMENTAL

The higher dose level will be 9Gy x 5 fractions, i.e. 45Gy/5 nonconsecutive once-daily fractions

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

In every group, the dose is prescribed at the edge of the PTV. To be approved, 95% of the PTV will be conformally covered by the prescription isodose surface and 99% of PTV will receive a minimum of 90% of the prescription dose.

Also known as: SBRT, Stereotaxis, Stereotactic Radiotherapy

40Gy/5fx; 42.5Gy/5fx; 45Gy/5fx

Eligibility Criteria

• Age: 75 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Fondazione Policlinico Tor Vergata

Rome, Rome, 00133, Italy

RECRUITING

Related Publications (25)

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Related Links

• Related Info

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rolando Maria D'Angelillo

  Fondazione Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Cedrone

CONTACT

+393669879224; radioterapia@ptvonline.it

Cecilia Sciommari

CONTACT

+390620908372; radioterapia@ptvonline.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Time to Event Key-Board, a dose escalation design study.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: October 7, 2021
• Study Start: January 1, 2021
• Primary Completion: November 11, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)