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
Updated on 19 February 2024
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 on19 February 2024

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

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

Loading...

Browse trials for

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

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
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.