Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serabelisib, Sapanisertib, Fulvestrant.
- Who it may be relevant to
- Registry conditions: HR+ HER2- Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug Serabelisib
Serabelisib is a selective, small molecule inhibitor of PI3Kα. - Drug Sapanisertib
Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase. - Drug Fulvestrant
Fulvestrant is a first-in-class SERD.
Primary outcome measures
- Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs) [Time frame: 2 years]
Secondary outcome measures (6)
- Objective Response Rate (ORR) [Time frame: Up to 2 years.]
- Progression Free Survival (PFS) [Time frame: Up to 5 years.]
- Progression Free Survival (PFS) at 6 months [Time frame: 6 months]
- Overall Survival (OS) [Time frame: Up to 5 years.]
- Clinical Benefit Rate (CBR) [Time frame: Up to 5 years.]
- Duration of Response (DoR) [Time frame: Up to 5 years.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- START Los Angeles — Los Angeles
- Rocky Mountain Cancer Centers — Lone Tree
- Oncology Associates of Oregon — Springfield
- SCRI Oncology Partners — Nashville
- Texas Oncology - Central/South — Austin
- START San Antonio — San Antonio
- Texas Oncology - San Aantonio — San Antonio
Identifiers
NCT: NCT07558733 · FTH-PIK-101