A clinical trial to compare the effectiveness and safety of adding GDC-0077 or a placebo to palbociclib and fulvestrant in people with breast cancer.

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Belgium
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
Trial Identifier:

NCT04191499 2019-002455-42 WO41554

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

      Hoffmann-La Roche Sponsor
      Phase 2/Phase 3 Phase
      NCT04191499 , WO41554 , 2019-002455-42 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

       

      How does the INAVO120 clinical trial work?
      This clinical trial is recruiting people who have a particular type of breast cancer that is hormone receptor (HR)-positive and HER2-negative. In order to take part, patients must have advanced breast cancer that cannot be fully removed with surgery or that has spread to other parts of their body (known as metastatic breast cancer).

      The purpose of this clinical trial is to compare the effects, good or bad, of adding GDC-0077 or placebo to treatment with palbociclib and fulvestrant in patients with breast cancer that has spread to other parts of the body. If you take part in this clinical trial, you will receive either GDC-0077 or placebo in addition to palbociclib and fulvestrant.

      How do I take part in this clinical trial?
      To be able to take part in this clinical trial, you must have been diagnosed with HR-positive, HER2-negative breast cancer that has spread to other parts of the body and cannot be fully removed with surgery. You must be 18 years of age or older. Women who are not yet post-menopausal must be treated with hormone therapy, starting at least 2 weeks before joining the study. Men are also advised to take this hormone therapy. 

      You must not have received any treatment for your breast cancer since it has been found to have spread to other parts of the body and you cannot join the trial if you are pregnant or breastfeeding.

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial.

      Before starting the clinical trial, you will be told about the risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or use non-hormonal contraception for safety reasons.

       

      What treatment will I be given if I join this clinical trial?
      Everyone who joins this clinical trial will be split equally into 2 groups randomly (like flipping a coin) and given either:

      • GDC-0077 (given as a tablet to swallow every day)
      • Palbociclib (given as a capsule/tablet to take every day for 3 weeks then no capsule/tablet taken for 1 week)
      • Fulvestrant (given as an injection every 2 weeks for the first month and then every 4 weeks after that)

      OR

      • Placebo (given as a tablet to swallow every day)
      • Palbociclib (given as a capsule/tablet to take every day for 3 weeks then no capsule/tablet taken for 1 week)
      • Fulvestrant (given as an injection every 2 weeks for the first month and then every 4 weeks after that)

      You will have a 1 in 2 chance of being placed in either group.

      This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given a tablet with no active ingredients but will still be given palbociclib and fulvestrant, which is the current standard treatment for this type of breast cancer. A placebo is used to make sure that the doctor or the patients do not sway the results of the clinical trial.

      Neither you nor your clinical trial doctor can choose or know the group you are in. However, if your safety is at risk, your clinical trial doctor can find out which group you are in.

       

      How often will I be seen in follow-up appointments and for how long?
      You will be given the clinical trial treatment, GDC-0077 OR placebo plus palbociclib and fulvestrant, for as long as it can help you. While receiving the study treatment, you will be seen by the clinical trial doctor to see how you are responding to the treatment and any side effects that you may be having. You are free to stop the study treatment at any time. After stopping the study treatment, you will still be seen by the clinical trial doctor within 1 month. After that, you will then be contacted by the clinical trial doctor every 3 months by telephone calls and/or for clinic visits. 

       

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04191499?term=WO41554&draw=2&rank=1

      Trial-identifier: NCT04191499

      Trial Summary

      This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

      Hoffmann-La Roche Sponsor
      Phase 2/Phase 3 Phase
      NCT04191499 , WO41554 , 2019-002455-42 Trial Identifier
      Inavolisib, Placebo, Palbociclib, Fulvestrant Treatments
      Breast Cancer Condition
      Official Title

      A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Confirmed diagnosis of HR+/HER2- breast cancer
      • Metastatic or locally advanced disease not amenable to curative therapy
      • Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
      • Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
      • Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
      • Consent to provide fresh or archival tumor tissue specimen
      • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1; "bone-only" disease, even if considered measurable, is not eligible
      • Eastern Cooperative Oncology Group Performance Status of 0 or 1
      • Life expectancy of > 6 months
      • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
      Exclusion Criteria
      • Metaplastic breast cancer
      • Any history of leptomeningeal disease or carcinomatous meningitis
      • Any prior systemic therapy for metastatic breast cancer
      • Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
      • Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
      • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
      • Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases are eligible
      • Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
      • Symptomatic active lung disease, or requiring daily supplemental oxygen
      • History of inflammatory bowel disease or active bowel inflammation
      • Anti-cancer therapy within 2 weeks before study entry
      • Investigational drug(s) within 4 weeks before randomization
      • Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
      • Chronic corticosteroid therapy or immunosuppressants
      • Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
      • Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

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