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SBRT in Early Breast Cancer in Elderly Women

ConditionBreast Neoplasm Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age75+
SponsorUniversity of Rome Tor Vergata

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: 40Gy/5fxExperimental treatment 1 intervention
Group B: 42.5Gy/5fxExperimental treatment 1 intervention
Group C: 45Gy/5fxExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

Locoregional disease control (LRC)

Absence of progressive tumor within the radiation field, it also requires evidence of an objective response (50% reduction in the product of two dimensions of the dominant tumor mass for measurable disease, as per RECIST criteria)

Time frame
5 years
2

Clinical complete response (cCR)

Disappearance of the target lesion; ideally, this determination will be made based on clinical evaluation and US and Rx Images

Time frame
6 months
3

Cosmesis assesed by Harvard scale

Cosmesis evaluation will be carried out before treatment, at last day of treatment and at every clinical examination with Harris scale scoring system. The Harvard scale proposed by Harris et al., which has been used to evaluate cosmetic outcome after BCT, is a 4-point scale that describes the global esthetic appearance of breasts as excellent, good, fair, or poor.

Time frame
5 years
4

Cosmesis assesed by BREAST-Q v2.0

Cosmesis evaluation will be carried out before treatment, at last day of treatment and at every clinical examination with Breast-Q v2.0 questionnaire. The BREAST-Q v2.0 is a rigorously developed patient-reported outcome (PRO) measure designed to evaluate outcomes among women undergoing different types of breast treatment. Among the 6 BREAST-Q modules we will use "Physical well-being chest Module", "Satisfaction with breast Module" and "Adverse Effects of Radiation Module". All scales are transformed into scores that range from 0-100, a higher score means greater satisfaction or better QOL

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rome Tor Vergata

Lead sponsor

Source ClinicalTrials.gov
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