New scan could reveal if breast cancer drugs are working in days
NCT ID NCT02608216
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase study tests whether a special PET scan using a tracer called FLT can show how breast cancer tumors respond to a combination of two drugs, ribociclib and paclitaxel. The study involves 20 people with metastatic breast cancer that has spread beyond the liver and bone. Researchers will take scans before and during treatment to see if changes in tumor activity can predict whether the therapy is working.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ribociclib (LEE011) and paclitaxel
- What this could lead to
- If successful, this imaging method could help doctors quickly tell if a breast cancer treatment is working, potentially guiding more personalized therapy.
- What could go wrong
- This is a very small, early-phase study focused on imaging, not on proving the treatment works. The results may not apply to all patients or lead to a direct benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Nov 2015
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At least 18 years of age 2. History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein. 3. At least one site of metastatic breast cancer that is outside of the liver and bone that is identified by standard imaging (e.g. CT, MRI, FDG PET/CT, ultrasound, x-ray) 4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. 5. Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel. Exclusion Criteria: 1. Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 4. Ineligible for the therapeutic trial UPCC 06115
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast neoplasm are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an oral drug replace injections for advanced breast cancer?
- Can a Three-Drug combo crack Triple-Negative breast cancer?
- Can a blood test reveal when breast cancer treatment stops working?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Zapping a few growing tumors may keep breast cancer drugs working longer
- Can a Two-Drug combo outsmart resistant breast and ovarian cancers?