Health TrialsbyHealthPanel

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

ConditionsBreast CancerBreast NeoplasmBreast TumorCancer of the Breast
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorProton Collaborative Group

About this trial

The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy.

This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.

Must be female.

Must be > = 50 years of age.

Must have a life expectancy of at least 5 years based on age and co-morbidities.

Disqualifiers

Previous history of ipsilateral invasive breast cancer or DCIS.

Any clinical or radiographically suspicious nodes, unless biopsy proven benign.

Non-epithelial malignancies such as sarcoma or lymphoma.

Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology.

Trial design

Design model

Single group

Treatments tested in this trial

  • Proton Radiotherapy

    Radiation

Treatment groups

132 Participants
are divided into 1 treatment group
Group A: Proton RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor.

Freedom from failure (FFF): The events for FFF will be the first ipsilateral breast cancer recurrence. It is expected that less than 3% of patients will experience an ipsilateral breast cancer recurrence (FFF ≥ 97%). A recurrence rate of ≥ 10% (FFF ≤ 90%) is considered unacceptable. Therefore, the null hypothesis is the FFF of ipsilateral breast cancer recurrence is 90% or lower and the alternative hypothesis is that FFF of ipsilateral breast cancer is 97% or higher.

Time frame
At 3 years

Secondary outcomes

1

Assess number and severity of acute and long-term toxicity of partial breast irradiation using proton therapy for the treatment of early stage breast cancer.

Time frame
On average every 6 months for life
2

To assess relationship between breast size and partial breast dosimetry.

Time frame
Average every 6 months for 3 years
3

Determine quality of life results.

Time frame
Average every 6 months for 3 years
4

To determine overall survival rate of patients with breast cancer treated with proton radiation.

Time frame
At 3 years

Other outcomes

Sponsors and contacts

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

Proton Collaborative Group

Lead sponsor

Source ClinicalTrials.gov
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