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RecruitingPhase 1 / Phase 2

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

Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other cancer treatments, and looks for early signs that they work. It is for women with advanced or spreading HR+/HER2- breast cancer, which uses hormones to grow but does not have high levels of HER2 protein.

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test confirms HR+/HER2- breast cancer.
  • The cancer is advanced or has come back and cannot be cured with surgery or radiation.
  • You have had at least one cancer treatment that works throughout the body.
  • You have at least one cancer area that can be measured or checked using study rules.
  • You can do all your usual activities, or can do light work but not hard physical activity.
  • You are not pregnant or breastfeeding. You have gone through menopause, had surgery to prevent pregnancy, or agree to use effective birth control.

Who can't join

  • You have triple-negative breast cancer or another active cancer within the past 24 months. Exceptions include fully removed local cancers, certain fully treated early cancers, and basal or squamous cell skin cancer.
  • Cancer has spread to your brain or spinal cord, unless you finished treatment to those areas and stopped steroids for this problem at least 4 weeks before study treatment.
  • You have a stomach feeding tube, poor absorption in your gut, surgically joined sections of your gut, a blocked bowel, or another condition that could affect how you absorb the study drugs.
  • You have serious heart or blood vessel problems, or a heart test shows a QTc interval longer than 480 milliseconds, a measure of the heart's electrical timing.
  • You have an active infection that is not controlled, or are taking part in another treatment trial.
  • You had radiation within 21 days before study treatment, or previously took drugs that block PI3K, AKT, mTORC1/2, or both PI3K and mTOR—signals involved in cell growth.
  • You recently used certain medicines that strongly affect CYP3A4 or CYP1A2, proteins that break down drugs. The study also limits medicines that affect CYP3A4 during treatment.
  • You have type 1 or type 2 diabetes treated with insulin.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. Exclusion Criteria: * 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.

Study sites (7)

CA

CO

OR

TN

TX