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New treatment option for Breast Cancer
Official title Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
ClinicalTrials.gov ID: NCT05592938
What this study is testing
- What it's testing
- Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, women only
You may be able to join if
- Age \> 18 years
- In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)
- Tumour \<3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
- \>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)
- Clinically node negative
You likely can't join if
- Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
- Tumour histology limited to lobular carcinoma only
- T4 disease
- Node positive or distant metastatic disease
- Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
- Currently pregnant or lactating
See the full eligibility criteria
- Age \> 18 years
- In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)
- Tumour \<3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
- \>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)
- Clinically node negative
- Negative margins (no tumour on ink)
- Recovered from surgery with the incision completely healed and no signs of infection
- Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
- Tumour histology limited to lobular carcinoma only
- T4 disease
- Node positive or distant metastatic disease
- Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
- Currently pregnant or lactating
- Presence of an ipsilateral breast implant or pacemaker
- Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy
- Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).
- Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol
- Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0
- Current or prior diagnosis of bilateral breast cancer
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Richmond, Virginia, United States
- Melbourne, Victoria, Australia
- São Paulo, São Paulo, Brazil
- Barrie, Ontario, Canada
- London, Ontario, Canada
- Oshawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Vitacura, Santiago Metropolitan, Chile
- Tel Aviv, Israel
- Florence, Italy
- Amman, Jordan, Jordan
- Nairobi, Kenya
- Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Richmond, Virginia, United States; Melbourne, Victoria, Australia; São Paulo, São Paulo, Brazil; Barrie, Ontario, Canada; London, Ontario, Canada and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.