Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2030-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients.

The main question\[s\] it aims to answer are:

* evaluate the rate of all grades of radiation-induced fibrosis at 4 years.
* evaluate poor/fair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

NCT01948726

Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost

COMPLETED NA

Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

NCT01349322

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3

Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

NCT04679454

Breast Cancer

RECRUITING NA

Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery

NCT03624478

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 +5 more

COMPLETED PHASE2

Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

NCT00208273

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, single-arm, phase II, non-randomized clinical trial that will test an hypofractionated schedule with high dose simultaneous integrated tumor bed boost set on a previous dose finding study. Patients will be treated with hypofractionated RT to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die). The study population will include early breast cancer patients with younger age (\< or= 50 years) and additional risk factors for local recurrence.

The primary objective of the study is to evaluate the rate of radiation-induced fibrosis at 4 years.The expected enrollment is 132 patients in 6 years. Each patient must have a minimum follow-up of 4 years.

The secondary objective is to evaluate cosmesis; other objectives are to evaluate quality of life (QoL) and the rate of local control.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypofractionated arm + concomitant tumor bed boost

Hypofractionation arm, 40 Gy in 15 fractions (2.67 Gy per fraction over 3 weeks) and a tumor bed boost to a total dose of 52.5 Gy in 15 fractions (3.5 Gy per fraction over 3 weeks).

Group Type EXPERIMENTAL

hypofractionated radiotherapy with tumor bed boost

Intervention Type RADIATION

hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hypofractionated radiotherapy with tumor bed boost

hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* histologically proven breast cancer who have undergone conservative surgery
* at least 3 inserted clips
* age: from 18 years old to 50 years
* at least one of the following risk factors: N1 disease, LVI, extensive intraductal component (\>25%), close margins (\<4 mm), non-hormone-sensitive disease, grading 3
* ECOG performance status \< 2
* adequate bone marrow (haemoglobin concentration \> 8 g/dl, white blood cell count \> 3000/mm3, platelet count \> 75000).

Exclusion Criteria

* Previous chest radiation treatment
* Bilateral breast cancer
* Neoadjuvant chemotherapy
* BMI \> 35
* Collagen diseases
* Pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No