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A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in Chinese patients with PIK3CA-mutant, hormone receptor-positive (HR+), HER2-negative (HER2-), endocrine-resistant metastatic breast cancer (mBC). Approximately 160 patients will be enrolled at around 16 centers in China.

The study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period.

PIK3CA mutation status must be determined in blood or tumor tissue using polymerase chain reaction (PCR)-based assays or next-generation sequencing (NGS) performed in a local clinical laboratory. Patients with locally confirmed PIK3CA mutations who meet all eligibility criteria will be enrolled and receive study treatment with inavolisib, ribociclib, and fulvestrant. Details of the treatment regimen are provided in the Study Treatment section. Study treatment will continue until radiologically confirmed disease progression as determined by the investigator, unacceptable toxicity, withdrawal of informed consent, or study termination, whichever occurs first.

Patients must have measurable disease according to RECIST v1.1. Patients with bone-only metastases are not eligible, even if the lesions are considered measurable. Locally advanced disease must be unsuitable for surgical resection or other local treatment with curative intent.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form (ICF).

Female, aged ≥18 years at the time of signing the ICF.

Age ≥60 years; OR

Age <60 years with amenorrhea for ≥12 consecutive months in the absence of oral contraceptives, hormone replacement therapy, or gonadotropin-releasing hormone (GnRH) agonists/antagonists, and with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range per local laboratory assessment; OR

Disqualifiers

Metaplastic breast carcinoma.

Any history of leptomeningeal disease or carcinomatous meningitis.

Prior systemic therapy for metastatic breast cancer (mBC).

Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), except neoadjuvant use ≤6 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Inavolisib + Ribociclib + Fulvestrant

    Drug

    A total of 160 Chinese patients who meet the eligibility criteria and are confirmed to have PIK3CA-mutant breast cancer will receive the following treatment regimen: * \*\*Inavolisib:\*\* 9 mg tablet, administered orally once daily (PO QD), on Days 1-28 of each 28-day cycle, starting from Cycle 1 Day 1; * \*\*Ribociclib:\*\* 600 mg capsule or tablet, administered orally once daily (PO QD), on Days 1-21 of each 28-day cycle, starting from Cycle 1 Day 1; * \*\*Fulvestrant:\*\* 500 mg administered by intramuscular injection (IM) on Days 1 and 15 of Cycle 1, and thereafter on Day 1 of each subsequent 28-day cycle (approximately every 4 weeks).

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Inavolisib + Ribociclib + FulvestrantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS), defined as the time from initiation of the first study treatment to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Time frame
From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months

Secondary outcomes

1

Objective Response Rate (ORR)

Objective response rate (ORR), defined as the proportion of patients who achieve a confirmed complete response (CR) and/or partial response (PR) on at least two consecutive assessments performed at least 4 weeks apart, as assessed by the investigator according to RECIST v1.1.

Time frame
From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months
2

Duration of Response (DOR)

Duration of response (DOR), defined as the time from the first documented CR or PR to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, as assessed by the investigator according to RECIST v1.1.

Time frame
From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months
3

Clinical Benefit Rate (CBR)

Clinical benefit rate (CBR), defined as the proportion of patients who achieve CR, PR, and/or stable disease (SD) lasting for at least 24 weeks, as assessed by the investigator according to RECIST v1.1.

Time frame
From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Hoffmann-La Roche

Collaborator

Novartis

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: