Inavolisib + Phesgo for Breast Cancer
(INAVO122 Trial)
Recruiting in Palo Alto (17 mi)
+225 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Hoffmann-La Roche
Must not be taking: PI3K inhibitors, AKT inhibitors
Disqualifiers: Diabetes, Liver disease, Lung disease, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called inavolisib combined with Phesgo, which includes three existing drugs. It targets patients with untreated HER2-positive advanced breast cancer. Inavolisib works by blocking growth signals in cancer cells, while Phesgo targets a protein on these cells to stop their growth and spread.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on medications for Type 2 diabetes or have a history of certain conditions like liver disease or lung disease, you may not be eligible to participate.
What data supports the effectiveness of the drug Inavolisib + Phesgo for breast cancer?
The FDA approved Phesgo, a combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf, for treating HER2-positive breast cancer based on studies showing it works as well as the intravenous versions of these drugs. This approval suggests that the subcutaneous form is effective for breast cancer treatment.
12345Is the combination of Inavolisib and Phesgo safe for human use?
Phesgo, a combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf, has been approved for use in HER2-positive breast cancer and is generally considered safe, with common side effects including hair loss, nausea, diarrhea, anemia (low red blood cell count), and weakness. Trastuzumab, part of Phesgo, has been used safely in self-administered injections without toxicity. However, specific safety data for Inavolisib in combination with Phesgo is not provided in the available research.
13678What makes the drug Inavolisib + Phesgo unique for breast cancer treatment?
The drug Phesgo, which combines pertuzumab, trastuzumab, and hyaluronidase-zzxf, is unique because it is administered as a subcutaneous injection (under the skin) rather than the traditional intravenous (IV) infusion, making it more convenient and less time-consuming for patients with HER2-positive breast cancer.
234910Eligibility Criteria
This trial is for adults with HER2-positive advanced breast cancer that hasn't been treated yet. They should have a certain gene mutation (PIK3CA), good heart function, and no diabetes requiring systemic treatment. People who've had specific eye conditions, severe liver disease, lung problems like pneumonitis, or inflammatory bowel disease can't join.Inclusion Criteria
My cancer is confirmed HER2 positive by a specialized lab test.
My cancer has a PIK3CA mutation according to a specialized test.
I am fully active or can carry out light work.
+4 more
Exclusion Criteria
I have had treatments for advanced HER2-positive breast cancer before starting the current therapy.
I have or had inflammatory bowel disease.
I have Type 2 diabetes and am on treatment, or I have a history of Type 1 diabetes.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction Therapy
Participants receive Phesgo plus Taxane-Based Chemotherapy
6-12 weeks
Maintenance Therapy
Participants receive Inavolisib plus Phesgo or Placebo plus Phesgo
21-day cycles, ongoing
Follow-up
Participants are monitored for safety and effectiveness after treatment
30-day safety follow-up, then every 6 months up to 111 months
Participant Groups
The study tests the safety and effectiveness of Inavolisib combined with Phesgo against a placebo with Phesgo after initial therapy. It's for those whose breast cancer has spread or can't be surgically removed.
3Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Therapy: Inavolisib plus PhesgoExperimental Treatment3 Interventions
Participants will be administered the treatments as outlined in the interventions section.
Group II: Induction Therapy: Phesgo plus Taxane-Based ChemotherapyExperimental Treatment2 Interventions
Participants will be administered the treatments as outlined in the interventions section.
Group III: Maintenance Therapy: Placebo plus PhesgoActive Control3 Interventions
Participants will be administered the treatments as outlined in the interventions section.
Phesgo is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Phesgo for:
- HER2-positive breast cancer
🇪🇺 Approved in European Union as Phesgo for:
- HER2-positive breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Renovatio Clinical - El PasoEl Paso, TX
JPS Health NetworkFort Worth, TX
Renovatio ClinicalThe Woodlands, TX
Allan Blair Cancer CenterRegina, Canada
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Hoffmann-La RocheLead Sponsor
References
Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. [2021]The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112).
A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">The introduction of human epidermal growth factor receptor 2 (HER2)-targeted treatment options, including dual HER2 blockade, has improved the prognosis for patients with HER2-positive breast cancer (BC) substantially. However, most of these treatments are administered via the intravenous (IV) route, which can present many challenges, such as long infusion and observation times, issues associated with repeated IV access, and increased strain on time and resources of medical centers and healthcare professionals. A fixed-dose combination of pertuzumab and trastuzumab for subcutaneous (SC) injection (pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO®, F. Hoffmann-La Roche Ltd, Basel, Switzerland; PH FDC SC)) has been approved for use alongside chemotherapy for early-stage and metastatic HER2-positive BC.
FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer. [2022]On June 29, 2020, the FDA approved pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection (Phesgo) for the treatment of patients with HER2-positive early-stage and metastatic breast cancer. Patients should be selected for therapy based on an FDA-approved companion diagnostic test. Approval was primarily based on the FeDeriCa trial, a randomized, open-label, multicenter comparability study of pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection compared with intravenous pertuzumab and intravenous trastuzumab administered in the neoadjuvant and adjuvant settings with chemotherapy for the treatment of patients with early breast cancer. The pharmacokinetic endpoints were, first, to demonstrate that the exposure of subcutaneous pertuzumab was not inferior to that of intravenous pertuzumab, and then to demonstrate that the exposure of subcutaneous trastuzumab was not inferior to that of intravenous trastuzumab. The primary endpoints were met with the observed lower limit of the two-sided 90% confidence intervals above the prespecified noninferiority margins. The most common adverse reactions were alopecia, nausea, diarrhea, anemia, and asthenia. The totality of the evidence demonstrated comparability of the subcutaneous product to intravenous, allowing for extrapolation and approval of all breast cancer indications for which intravenous trastuzumab and pertuzumab are approved.
Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. [2022]A subcutaneous formulation of trastuzumab has been developed, offering potential improvements in patient convenience and resource use compared with the standard intravenous infusion of the drug. We compared the pharmacokinetic profile, efficacy, and safety of the subcutaneous and intravenous formulations in patients with HER2-positive early breast cancer.
Infective complications in cancer patients treated with subcutaneous versus intravenous trastuzumab and rituximab: An individual patient data meta-analysis. [2023]Investigation of infection risk with subcutaneous versus intravenous trastuzumab and rituximab administration in an individual patient data (IPD) and published data meta-analysis of randomised controlled trials (RCTs).
Population pharmacokinetic and exploratory exposure-response analysis of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer in the FeDeriCa study. [2022]To characterize pertuzumab pharmacokinetics (PK) in FeDeriCa (NCT03493854: fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection [PH FDC SC] versus intravenous pertuzumab plus trastuzumab); derive individual pertuzumab exposures in the PH FDC SC arm for subsequent pertuzumab exposure-response (ER) analyses; compare observed trastuzumab PK with predicted exposures from a previous SC trastuzumab model; assess whether pertuzumab affects trastuzumab PK; evaluate pertuzumab exposure-efficacy and -safety relationships and support the approved SC dosing regimen.
HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes. [2020]Label="BACKGROUND" NlmCategory="BACKGROUND">Pertuzumab (Perjeta®), a HER2/neu receptor antagonist, was approved by the US Food and Drug Administration in June 2012 for use in the first-line setting for patients with HER2-positive metastatic breast cancer (mBC).
Subcutaneous auto-administration of trastuzumab following therapeutic education: A case report. [2019]Trastuzumab is a monoclonal antibody used to treat human epidermal growth receptor 2 positive (HER2+) breast cancers either by itself or in combination with other chemotherapy medication. Marketing authorization was granted for a subcutaneous form of the antibody in 2014. In this case report, we discuss our experience with a patient who took part in a therapeutic education program on self-administration of trastuzumab. We demonstrate that these types of self-administered injections are not only possible but also are toxicity-free. Based on the tolerance data and our patient's experience, we propose that the current regulations be relaxed regarding the availability of trastuzumab subcutaneous form in order to develop a cheaper "city scheme," i.e. self-administered injections.
The Cost-Effectiveness of Pertuzumab for the Treatment of Metastatic HER2+ Breast Cancer in Czechia: A Semi-Markov Model Using Cost States. [2023]This article estimates the cost-effectiveness of adding pertuzumab to the combination of trastuzumab and docetaxel within the first-line treatment for metastatic breast cancer with the amplification of HER2+.
Combination pertuzumab, trastuzumab, and taxane for metastatic breast cancer after first progression: a single institution's experience. [2016]The addition of pertuzumab to trastuzumab and taxane therapy was shown to be an effective first-line treatment for patients with HER2-positive metastatic breast cancer.