Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    30
  • sponsor
    Weill Medical College of Cornell University
Send
Updated on 5 August 2020
See if I qualify
metastasis
breast carcinoma
lumpectomy
invasive breast cancer
carcinoma
systemic therapy
breast irradiation
partial breast irradiation
radiotherapy to breast

Summary

The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins.

Description

Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for Radiation Therapy (RT) nave patients at New York Presbyterian using EBRT.

The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Details
Condition Breast Cancer, Breast Cancer
Age 19years - 90years
Treatment 600cGY x 5 fractions
Clinical Study IdentifierNCT04371913
SponsorWeill Medical College of Cornell University
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Isolated ipsilateral unifocal breast lesions
Limited size (< 2-3 cm) without evidence of skin involvement
Histologically proven invasive breast carcinoma
Negative histologic margins of resection
Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
No synchronous distant metastases
Age 50 years
months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
Patient preference
Technical feasibility
Every kind of systemic therapy is allowed
Informed consent for clinical and research purposes signed

Exclusion Criteria

Regional recurrences (axillary, supraclavicular)
Positive histologic margins at resection
Metastatic disease
Poor cosmesis from previous surgery and RT
Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment
Extensive Intraductal Component
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

metastasis
breast carcinoma
lumpectomy
invasive breast cancer
carcinoma
systemic therapy
breast irradiation
partial breast irradiation
radiotherapy to breast

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.