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Trial record 1 of 1 for:    NCT04191499
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A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT04191499
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of GDC-0077 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: GDC-0077 Drug: Placebo Drug: Palbociclib Drug: Fulvestrant Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GDC-0077 + Palbociclib + Fulvestrant
Participants will receive GDC-0077, palbociclib, and fulvestrant.
Drug: GDC-0077
Participants will receive oral GDC-0077 on Days 1-28 of each 28-day cycle.

Drug: Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Drug: Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.

Placebo Comparator: Placebo + Palbociclib + Fulvestrant
Participants will receive placebo, palbociclib, and fulvestrant.
Drug: Placebo
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.

Drug: Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Drug: Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years) ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 6 years ]
  2. Best Overall Response Rate (BOR) [ Time Frame: Up to 6 years ]
  3. Duration of Response (DOR) [ Time Frame: From the first occurrence of a CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years) ]
  4. Clinical Benefit Rate (CBR) [ Time Frame: Up to 6 years ]
  5. Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to 6 years) ]
  6. Time to Deterioration (TTD) in Pain [ Time Frame: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days) ]
  7. TTD in Physical Function [ Time Frame: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days) ]
  8. TTD in Role Function [ Time Frame: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days) ]
  9. TTD in Global Health Status [ Time Frame: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days) ]
  10. Percentage of Participants with Adverse Events [ Time Frame: From randomization through the end of study (up to 6 years) ]
  11. Plasma Concentration of GDC-0077 [ Time Frame: At pre-defined intervals from baseline to the end of study (up to 6 years) ]
  12. Plasma Concentration of Palbociclib [ Time Frame: At pre-defined intervals from baseline to the end of study (up to 6 years) ]
  13. Plasma Concentration of Fulvestrant [ Time Frame: At pre-defined intervals from baseline to the end of study (up to 6 years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191499


Contacts
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Contact: Reference Study ID Number: WO41554 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04191499    
Other Study ID Numbers: WO41554
2019-002455-42 ( EudraCT Number )
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Palbociclib
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action