Clinical trial for HR+ HER2- Breast Cancer
Official title Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07558733
What this study is testing
What is Serabelisib?
Serabelisib is an investigational oral medicine being studied as a potential treatment for HR+ HER2- advanced or metastatic breast cancer. It is designed to selectively inhibit the PI3Kα enzyme, which may reduce cancer cell growth signals.
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 sapanisertib and serabelisib (PIKTOR) with fulvestrant can be safe and may help people with HR+ HER2- advanced breast cancer.
- Who it's for
- You may be able to join if you have HR+ HER2- advanced or metastatic breast cancer and have tried other treatments.
- What's involved
- You will receive sapanisertib and serabelisib (PIKTOR) with fulvestrant, and you will have regular visits and tests to check safety and how well it works.
- Time commitment
- The study lasts several months, with multiple clinic visits and blood tests during the treatment period.
- Phase 2: a mid-size study of how well it works
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
- Histologically confirmed diagnosis of HR+/HER2- breast cancer.
- Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent.
- Participant has received at least one prior systemic therapy.
- At least 1 measurable or evaluable target lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.
You likely can't join if
- Participants with triple-negative breast cancer.
- Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of...
- Active malignancy (except for breast cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell...
- Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that...
- Significant cardiovascular impairment.
- Active, uncontrolled infection.
See the full eligibility criteria
- Histologically confirmed diagnosis of HR+/HER2- breast cancer.
- Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent.
- Participant has received at least one prior systemic therapy.
- At least 1 measurable or evaluable target lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.
- Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.
- Participants with triple-negative breast cancer.
- Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting...
- Active malignancy (except for breast cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment.
- Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
- Significant cardiovascular impairment.
- Active, uncontrolled infection.
- Concurrent participation in another therapeutic clinical trial.
- Prior radiation therapy within 21 days prior to start of study treatment.
- Participants who have received a prior PI3K, AKT, mTORC1/2, or dual PI3K/mTOR inhibitor.
- Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with...
- Prolongation of QTc interval to \>480 ms.
- Type 1 or Type 2 diabetes mellitus on insulin.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Lone Tree, Colorado, United States
- Springfield, Oregon, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
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 Los Angeles, California, United States; Lone Tree, Colorado, United States; Springfield, Oregon, United States; Nashville, Tennessee, United States; Austin, Texas, United States; San Antonio, Texas, United States. 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.