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A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHoffmann-La Roche

About this trial

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification

Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy

Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)

Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

Disqualifiers

Stage IV (metastatic) BC

Inflammatory BC (cT4d)

Bilateral invasive BC

History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inavolisib

    Drug

    Inavolisib will be administered as per the schedule specified in the arms

  • Ribociclib

    Drug

    Ribociclib will be administered as per the schedule specified in the arms

  • Letrozole

    Drug

    Letrozole will be administered as per the schedule specified in the arms

  • Giredestrant

    Drug

    Giredestrant will be administered as per the schedule specified in the arms

Treatment groups

120 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Arm AExperimental treatment 3 interventions
Group B: Arm BExperimental treatment 3 interventions
Group C: Arm CExperimental treatment 3 interventions
Group D: Arm D (non-randomized)Experimental treatment 3 interventions
Group E: Arm EExperimental treatment 3 interventions
Group F: Arm FExperimental treatment 3 interventions
Group G: Arm GExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Events (AEs)

Time frame
From first dose up to 30 days after last dose (approximately 8 months)

Secondary outcomes

1

Percentage of Participants with Total Pathological Complete Response (pCR)

Time frame
Up to approximately 8 months
2

Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1)

Time frame
Up to approximately 8 months
3

Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC)

Time frame
Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days
4

Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire

Time frame
Up to approximately 8 months

Other outcomes

Sponsors and contacts

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

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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