Neoplasms

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Breast Neoplasms

Breast Diseases

Skin Diseases

Accelerated Partial Breast Irradiation using Mammosite RTS

Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy

Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.

Breast Brachytherapy with Mammosite RTS

Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Intensity Modulated Radiotherapy

Dennis Carter, MD

Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.

Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy

Charles Leonard, MD

Rocky Mountain Cancer Centers

Dennis Carter, MD, Principle Investigator

All Drugs and Chemicals

Estrogens

APBI 28 Gy in 5 fractions of 5.6 Gy, using external radiotherapy with modulated intensity technique (IMRT)

Carlos Míguez Sánchez

Carlos Miguez Sanchez

The aim of this observational study is to evaluate a dose fractionation scheme for APBI using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients as it decreases the treatment number of sessions and improves the efficiency and accessibility.

Breast cancer is the most common tumor among women; although its treatment used to be very aggressive, nowadays is based on the minimum effective treatment.

In non-metastatic patients, the therapeutical strategy is based on surgery, systemic therapy and radiotherapy. Usually in the early stages of the disease, the treatment begins with a conservative surgery followed by adjuvant therapy.

It´s been proved that the majority of relapses after conservatory surgery occur near the surgical bed which suggests that the main benefit of radiotherapy treatment lies in its primary effect on residual microscopic disease in the surgical bed. Regarding the radiotherapy used after conservative surgery, it´s accepted as standard treatment hypofractionated schemes, after they have demonstrated at least the same grade of effectiveness as the classic fractionation in terms of locoregional control, survival, aesthetic results or toxicity.

One of the options of hypofractionated schemes is APBI (Accelerated Partial Breast Irradiation), that by reducing the volume of the radiated breast and an accelerated dose fractionation scheme, can eliminate the residual microscopic disease in the surgical bed. The main advantage of APBI is that can shorten the overall time (total treatment time) by increasing the dose per fraction.

In patients who meet the following criteria:≥ 45 years or 40-44 if there isn´t any other risk factor, diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) and that have undergone conservative surgery without ganglionar involvement (pN0) of any histological degree except from invasive lobular carcinoma and with a size ≤ 3 cm, with a free margin of at least 2 mm, as well as with positive and negative estrogen receptor tumors; APBI is currently considered standard treatment.

This radiotherapy modality can be administered using 4 different techniques: interstitial brachytherapy, spherical balloons, intraoperative radiotherapy with electrons or with dedicated kilovoltage (RIO) systems and External Radiotherapy (3D shaped RT or modulated intensity radiotherapy - IMRT-). Each of them have their advantages and disadvantages, without any of them being superior to the others in terms of survival or local control, however, IMRT achieves a more shaped and uniformed dose after conservative surgery.

The aim of this observational study is to evaluate a dose fractionation scheme for APBI (28 Gy in 5 fractions of 5.6 GY, 5 days/week) using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients.

Accelerated Partial Irradiation of the Breast: New Altered Fractionation

Measurement of dose in the heart, ipsilateral and contralateral lung, ipsilateral and contralateral breast taking into account the acceptable and optimal dose limit.

Clinical or imaged based detection of the already treated breast cancer tumor (local relapse) or the ipsilateral regional ganglionic chains: armpit, supraclavicular cavity or internal breast chain (regional relapse).

The disease free survival is the time that passes from the end of the treatment until a control is done or takes place a relapse (local or distant).

The disease overall survival is the time that passes from the end of the treatment until a control is done or the patient´s death.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days

Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days

accelerated partial breast irradiation - 3D-conformal planning

accelerated partial breast irradiation - IMRT planning

Rachel Lei, BS

William Daniel, MD

Kathryn Howell, MD

Andrew Antell, MD

Meera Patel, MD

Ralph Wright, MD

Robert LaPorte, MD

Daniel Chin, MD

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy

Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit

Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue

Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit

Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)

Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)

Track breast-cancer free survival status of study participants (efficacy outcome measure)

Track the overall survival status of all study participants (efficacy outcome measure)

Accelerated, hypofractionated partial breast radiotherapy.

3 dose schemes followed for 6 months each.

APBI (Dose Escalation)

Contura MLB Breast Brachytherapy Catheter

Atif Khan, MD

Douglas W. Arthur, MD

Mihai Ghilezan, MD

To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.

Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB

Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial

C. R. Bard

SenoRx, Inc.

The APBI group will be irradiated with a dose of 30Gy in 5 fractions in 5 working days.

The control group of patients will be irradiated with a standard accelerated mode within 20 working days.

accelerated partial breast irradiation to the surgery bed (5 x 6,0 Gy; in 5 working days)

APBI

accelerated whole breast irradiation with the boost to tumor bed (15x 2,67 Gy + 5x 2,0 Gy, every working day)

Petr Burkon, M.D., Ph.D.

The adjuvant radiotherapy (RT) of the early-stage breast cancer patients as local treatment aims to eliminate the potential microscopic residual disease in the surgery bed or satellites in its neighborhood. Nowadays accelerated partial breast irradiation (APBI) is recommended for highly selected patients. This prospective randomized study compares the targeted external beam APBI with commonly used accelerated whole-breast irradiation (WBI) in terms of feasibility, safety, tolerance, and cosmetic effects. It is designed as non-inferiority trial and its aim is to increase the level of evidence for establishment of external beam APBI in indicated patients into daily clinical practice.

Early-stage breast cancer patients after partial mastectomy are screened for eligibility. The inclusion criteria are age ˃ 50 years, non-lobular carcinoma histology, size ≤ 2 cm, negative margins ≥ 2 mm, L0, ER-positive, HER-2 negative. Enrolled patients are equally randomized into two arms according to radiotherapeutic regiment - external beam APBI (5× 6 Gy) and accelerated whole breast irradiation with the boost (15× 2,67Gy + 5× 2Gy). The follow-up visits are planned at the end of RT and 1, 3, 6, 9, and 12 months after radiation, in the second year every 4 months and then every 6 months. Cosmetics results and toxicity are evaluated using questionnaires, CTCAE criteria, and photodocumentation of the irradiated chest. The main objective of presented study is to evaluate the feasibility, safety, tolerance, and cosmetic effects of SBRT irradiation to the surgery bed in five fractions. In addition to standard clinical examination and evaluation of acute and late side effects, patients together with clinicians and nurses will independently complete a questionnaire on the impact of irradiation on the cosmetic effect. The technique of targeted external beam APBI should demonstrate better feasibility and less toxicity than the standard regimen in the adjuvant setting in treating early-stage breast cancer patients. Consequently, the presented study should increase the level of evidence for RT-indicated patients to the establishment of external APBI into daily clinical practice.

The trial is designed as binary outcome parallel group non-inferiority trial.

Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

Adjuvant Partial-breast Irradiation of Early-stage Breast Cancer Using Stereotactic Body Radiation Therapy

Comparison of acute and late toxicity of the APBI of the early stage breast cancer with accelerated irradiation regimen.

Comparison of cosmetic effects of the APBI of the early stage breast cancer with accelerated irradiation regimen. Cosmetic effects independently evaluated by patient, physician, and nurse scored using Harvard scale (4-point Likert scale). The scale contains 4 values - nearly identical as untreated (the best outcome), slightly different, clearly different, seriously distorted (the worst outcome)

Evaluation of feasibility of the APBI regimen based on the proportion of patients who completed radiation in a total of 10 days and the proportion of patients who were irradiated exactly according to technical guidelines.

Comparison of tolerance of the APBI of the early stage breast cancer with accelerated irradiation regimen. The toxicity was evaluated by CTCAE criteria (Common Terminology Criteria for Adverse Events). The outcome to define the tolerance a safety was CTCAE grade II or greater skin toxicity.

Comparison of safety of the APBI of the early stage breast cancer with accelerated irradiation regimen. The toxicity was evaluated by CTCAE criteria (Common Terminology Criteria for Adverse Events). The outcome to define the tolerance a safety was CTCAE grade II or greater skin toxicity.

Quality of Life assessment using the standardized European Organisation for Research and Treatment of Cancer (EORTC) questionnaire QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Quality of Life assessment using the standardized European Organisation for Research and Treatment of Cancer (EORTC) questionnaire with special module for patients with breast cancer (Breast QLQ-BR45). All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.

Assessment of effectivity of the treatment method by evaluating subsequent endpoints such as LC (local control) and OS (overall survival). Overall survival (OS) is defined as the time from randomization to death from any cause. Local control (LC) is defined as the time from randomization to the first local recurrence.

Masaryk Memorial Cancer Institute

Symptoms and General Pathology

Recurrence

Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq

Interstitial multicatheter brachytherapy

Vratislav Strnad, MD, Prof.

Godehard Lahmer, MD

Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.

Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.

Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer

Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer

to assess the incidence and severity of acute and late side effects of brachytherapy

University Hospital Erlangen

Neoplasm Recurrence, Local

Disease Attributes

Neoplastic Processes

Patients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks.

Patients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks.

Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.

Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.

Shulian Wang, M.D.

This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.

Randomized Trial of Accelerated Partial Breast Irradiation

A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer

The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria:

acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result

ipsilateral breast and axillary nodal recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy	NCT01185145	Breast Cancer	Breast Brachyth... Intensity Modul...	40 Years -	Rocky Mountain Cancer Centers
Accelerated Partial Irradiation of the Breast: New Altered Fractionation	NCT04101656	Breast Cancer		40 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy	NCT01185132	Breast Cancer	accelerated par... accelerated par...	40 Years -	Rocky Mountain Cancer Centers
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB	NCT01072838	Breast Cancer	APBI (Dose Esca... Contura MLB Bre...	50 Years -	SenoRx, Inc.
Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy	NCT06007118	Early-stage Bre...	APBI WBI	50 Years -	Masaryk Memorial Cancer Institute
Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer	NCT01175694	Breast Cancer	Interstitial mu...	50 Years -	University Hospital Erlangen
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB	NCT01072838	Breast Cancer	APBI (Dose Esca... Contura MLB Bre...	50 Years -	SenoRx, Inc.
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB	NCT01072838	Breast Cancer	APBI (Dose Esca... Contura MLB Bre...	50 Years -	SenoRx, Inc.
Randomized Trial of Accelerated Partial Breast Irradiation	NCT03583619	Breast Neoplasm... Neoplasm Recurr...	APBI WBI	45 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for apbi

Every month we try and update this database with for apbi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for apbi

Every month we try and update this database with for apbi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for apbi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.