What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving endocrine therapy like Selective Estrogen Receptor Degraders (SERDs) such as Giredestrant, include tamoxifen and aromatase inhibitors. Known side effects of these treatments can include hot flashes, vaginal discharge or dryness, nausea, and an increased risk of thromboembolic events. Aromatase inhibitors may also lead to loss of bone density and increased risk of fractures. Tamoxifen has been associated with a slight increase in the risk of endometrial carcinoma and, less frequently, ocular and hepatotoxicity.

What prior FDA approvals exist?

The FDA has approved several endocrine therapies for the treatment of breast cancer, particularly for estrogen receptor-positive (ER-positive) types. Fulvestrant, a Selective Estrogen Receptor Degrader (SERD), is one such drug that has been approved and is used in various dosing regimens to improve progression-free survival in advanced breast cancer. Other endocrine therapies include aromatase inhibitors like letrozole and anastrozole, and selective estrogen receptor modulators (SERMs) such as tamoxifen. These treatments are often used in different combinations and sequences to manage hormone receptor-positive breast cancer effectively.

What other types of research exist?

Promising alternatives to Giredestrant for breast cancer treatment in 2024 include: 1) Elacestrant, another oral SERD that has shown efficacy in clinical trials for ER-positive, HER2-negative breast cancer. 2) Newer aromatase inhibitors like Letrozole and Anastrozole, which continue to be effective in hormone receptor-positive breast cancer. 3) CDK4/6 inhibitors such as Palbociclib, Ribociclib, and Abemaciclib, which are often used in combination with endocrine therapy to improve outcomes. 4) PI3K inhibitors like Alpelisib for patients with PIK3CA-mutated breast cancer. These alternatives offer different mechanisms of action and can be considered based on individual patient profiles and prior treatment responses.

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Aromatase Inhibitor

Giredestrant for Advanced Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent

For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment

Must not have

Advanced, symptomatic, visceral spread that is at risk of life-threatening complications

Active cardiac disease or history of cardiac dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death from any cause (up to approximately 36 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing giredestrant, a new drug, to see if it works better than usual hormone treatments for certain breast cancer patients. It targets patients whose cancer grows with the help of estrogen and who have already tried other treatments. The drug aims to block a protein that helps the cancer grow.

Who is the study for?

This trial is for postmenopausal or premenopausal women with ER-positive, HER2-negative advanced breast cancer who've had 1-2 systemic therapies but not more than one targeted therapy. They must have good organ function and agree to LHRH agonist therapy if premenopausal. Exclusions include active heart disease, uncontrolled brain metastases, life-threatening visceral spread, prior SERD treatment (except fulvestrant), investigational drug use within 28 days, or being pregnant/breastfeeding.

What is being tested?

The study compares the effectiveness of Giredestrant against a physician's choice of endocrine monotherapy in patients with certain types of advanced breast cancer. It's an open-label Phase II trial where participants are randomly assigned to receive either Giredestrant or another hormone therapy chosen by their doctor.

What are the potential side effects?

Potential side effects may include hot flashes, joint pain, fatigue, nausea and vomiting related to hormonal treatments like Fulvestrant or Aromatase Inhibitors. Side effects specific to Giredestrant aren't detailed but could be similar due to its nature as a selective estrogen receptor degrader.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer cannot be cured with surgery or radiation.

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I am willing to undergo hormone therapy if I am a premenopausal or perimenopausal woman, or a man.

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My tumor is ER-positive and HER2-negative.

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My cancer has worsened after 1 or 2 treatments, but I've only had one targeted therapy.

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I am a woman who has gone through menopause or am approaching it.

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I am fully active or can carry out light work.

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I have cancer that can be measured by scans or have a specific type of bone lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to vital organs and could cause serious health issues.

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I have heart problems or have had them in the past.

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I do not have active brain metastases or related conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death from any cause (up to approximately 36 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death from any cause (up to approximately 36 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death from any cause (up to approximately 36 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Secondary study objectives

Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1

Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1

Investigator-Assessed PFS, in Subgroups Categorized by Estrogen Receptor 1 (ESR1) Mutation Status

+11 more

Side effects data

From 2021 Phase 2 trial • 221 Patients • NCT04436744

41%

Neutropenia

23%

Neutrophil count decreased

22%

Asthenia

14%

Nausea

14%

Hot flush

13%

Leukopenia

13%

White blood cell count decreased

11%

Anaemia

11%

Arthralgia

Fatigue

Mucosal inflammation

Diarrhoea

Vomiting

Rash

Alopecia

Headache

Constipation

Procedural pain

Hip fracture

COVID-19

Pyrexia

Myocardial infarction

Uterine perforation

Aspartate aminotransferase increased

Alanine aminotransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

Giredestrant + Palbociclib

Anastrozole + Palbociclib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GiredestrantExperimental Treatment2 Interventions

Group II: Physician Choice of Endocrine MonotherapyActive Control2 Interventions

The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Giredestrant

2019

Completed Phase 2

~300

LHRH Agonist

2013

Completed Phase 2

~130

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments often target specific mechanisms to inhibit cancer growth. Endocrine therapies, such as Selective Estrogen Receptor Degraders (SERDs) like giredestrant, work by binding to estrogen receptors on cancer cells, leading to receptor degradation and blocking estrogen-driven tumor growth. This is crucial for patients with estrogen receptor-positive (ER-positive) breast cancer, as it directly targets the hormone dependency of their tumors. Other common treatments include chemotherapy, which kills rapidly dividing cells, and HER2-targeted therapies, which inhibit the HER2 protein that promotes cancer cell growth. Understanding these mechanisms helps tailor treatments to the cancer's specific characteristics, improving efficacy and patient outcomes.