Trial comparing treatments for Breast Cancer
Official title A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
ClinicalTrials.gov ID: NCT07405801
What this study is testing
What is Inavolisib?
An investigational oral medicine being studied as a potential treatment for advanced hormone receptor‑positive, HER2‑negative breast cancer. It is designed to block the PI3K pathway, which can help slow the growth of cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the three‑drug combo works better and is safe compared with a pretend treatment.
- Who it's for
- You may be able to join if you have advanced HR‑positive, HER2‑negative breast cancer that stopped responding to hormone therapy and you are starting first‑line treatment.
- What's involved
- You will take pills of inavolisib, ribociclib and fulvestrant, or a pretend pill, while doctors check your health with regular visits and tests.
- Time commitment
- The study lasts until the cancer gets worse, with clinic visits every few weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to...
- Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical...
- Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have...
- Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a...
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
You likely can't join if
- Metaplastic breast cancer
- Radiotherapy within 2 weeks before randomization
- Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g...
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic...
- Any history of leptomeningeal disease or carcinomatous meningitis
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Palo Alto, California, United States
- Jacksonville, Florida, United States
- Marshall, Minnesota, United States
- Jamaica, New York, United States
- Aberdeen, South Dakota, United States
- Mitchell, South Dakota, United States
- Pierre, South Dakota, United States
- Sioux Falls, South Dakota, United States
- Yankton, South Dakota, United States
- Milwaukee, Wisconsin, United States
- Buenos Aires, Argentina
- Caba, Argentina
- Capital Federal, Argentina
- Rosario, Argentina
- Vitória, Espírito Santo, Brazil
- Brasília, Federal District, Brazil
- Curitiba, Paraná, Brazil
- São Paulo, São Paulo, Brazil
- Ottawa, Ontario, Canada
+ 37 more site(s).
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, but 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Palo Alto, California, United States; Jacksonville, Florida, United States; Marshall, Minnesota, United States; Jamaica, New York, United States; Aberdeen, South Dakota, United States and 51 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.