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RecruitingLast updated: 28 March 2024

pionERA: This study is comparing two types of hormone therapy when given in combination with targeted therapy in people with ER+ HER- advanced breast cancerA Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Clinical summary

Summary

Eligible participants will be randomly assigned to one of two treatment arms. Treatment cycles are 28-days.

In the Experimental Arm, participants will receive Giredestrant hormone therapy + the Investigator's Choice of CDK4/6 inhibitor targeted therapy (either Palbociclib, Ribociclib or Abemaciclib).

Giredestrant (30mg) will be given orally once a day on Days 1-28 of each cycle. If chosen, Abemaciclib (150mg) will be given orally twice daily on Days 1-28, Palbociclib (125mg) will be given orally once daily on Days 1-21, and Ribociclib (600mg) will be given orally once daily on Days 1-21.

In the Active Comparator Arm, participants will receive Fulvestrant hormone therapy + Investigator's Choice of CDK4/6 inhibitor targeted therapy (either Palbociclib, Ribociclib, or Abemaciclib).

Fulvestrant (500mg) will be given intramuscularly on Days 1 and 15 of Cycle 1, and on Day 1 of each subsequent treatment cycle. If chosen, Abemaciclib (150mg) will be given orally twice daily on Days 1-28, Palbociclib (125mg) will be given orally once daily on Days 1-21, and Ribociclib (600mg) will be given orally once daily on Days 1-21.

In both arms, pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each cycle.

Conditions

This trial is treating patients with ER+ HER2- advanced breast cancer who have developed resistance to adjuvant hormone therapy (also called endocrine therapy)

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

pionERA

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Eligibility

Inclusion

  • Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or archived tumor sample)
  • Confirmed ESR1 mutation status (ESR1m vs. ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
  • Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant CDK4/6i is allowed.
  • No prior systemic anti-cancer therapy for advanced disease
  • Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • For pre/perimenopausal women and for men: treatment with LHRH agonist therapy (as per local guidelines) for the duration of study treatment is required

Exclusion

  • Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
  • Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  • Active cardiac disease or history of cardiac dysfunction
  • Clinically significant history of liver disease

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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