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Sapanisertib and Serabelisib for HR+/HER2- Advanced Breast Cancer

This study is testing sapanisertib and serabelisib, alone or with fulvestrant, for people with HR+/HER2- (Hormone Receptor-positive, Human Epidermal growth factor Receptor 2-negative) advanced or metastatic breast cancer. Sapanisertib targets mTOR and serabelisib targets PI3K, both pathways involved in cancer growth. You may be able to join if you have HR+/HER2- breast cancer that has spread or come back, and you've already had at least one other treatment. The main goal is to see how safe these drugs are and what side effects they cause. The study plans to enroll 32 participants. The current recruitment status is unclear.

Study design
This is a Phase 1b/2, multi-center, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is designed to test different doses and combinations of the drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07558733

Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Faeth Therapeutics
~32 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:SerabelisibSapanisertibFulvestrant

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Measured over 2 years

Conditions

HR+ HER2- Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 5 states
Texas3
California1
Colorado1
Oregon1
Tennessee1

Who to contact

Medical Monitor
[email protected]
(708) 406-9282
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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 treatment in this study.
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. Fully resected localized malignancies are eligible.
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 strong CYP3A4 inhibitors or inducers during the study.
Prolongation of QTc interval to \>480 ms.
Type 1 or Type 2 diabetes mellitus on insulin.

What this trial measures

  • Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)2 years

    Graded according to the National Cancer Institute (NCI CTCAE v5.0).