No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for women aged 50 and older who have early-stage breast cancer or ductal carcinoma in situ. Participants will receive a specific type of radiation treatment aimed at minimizing the number of visits to the clinic while still being effective.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 50 or older.
I have been diagnosed with breast cancer or ductal carcinoma in situ.
I have had breast-conserving surgery.
I am planning to receive radiation therapy.
You may not be able to join if
I have had a breast reduction surgery that affects targeting.
I have bilateral breast cancer that needs radiation on both sides.
I have symptoms showing that my cancer has spread to other parts of my body.
I have previously received radiation to the same breast.
I have an autoimmune condition.
I have collagen vascular disease.
I have a pT4 tumor.
I need regional nodal radiation therapy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy.
The FAST-Forward trial previou…
This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy.
The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.
Trial Locations
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Status
Eligibility Criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
* Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Women ≥ 50…
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
* Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.
* Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
* Subjects planned to receive either SOC whole breast 3D conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.
* Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, per the discretion of the treating radiation oncologist.
* Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator.
Exclusion Criteria:
* Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).
* Synchronous bilateral breast cancer requiring bilateral radiation therapy.
* Clinical or imaging evidence of distant metastases.
* Prior ipsilateral breast or thoracic radiation.
* Autoimmune conditions
* Collagen Vascular Disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others)
* Patients with pT4 tumors.
* Patients recommended to receive regional nodal irradiation with associated radiation risks
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