What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving endocrine therapies like Selective Estrogen Receptor Degraders (SERDs) such as Giredestrant, aromatase inhibitors, and tamoxifen, often have side effects. SERDs can cause hot flashes, fatigue, and joint pain. Aromatase inhibitors are associated with bone density loss, increased fracture risk, and cardiovascular issues. Tamoxifen may lead to vasomotor symptoms, vaginal discharge or dryness, nausea, depression, and a slight increase in thromboembolic events. Additionally, tamoxifen has a rare but significant risk of endometrial carcinoma.

What prior FDA approvals exist?

The FDA has approved several hormonal therapies for the treatment of breast cancer, particularly for hormone receptor-positive types. Fulvestrant, a Selective Estrogen Receptor Degrader (SERD), is one such drug that has been approved and is used in postmenopausal women with advanced breast cancer. Other related hormonal therapies include selective estrogen receptor modulators (SERMs) like tamoxifen, which has been widely used for both early and advanced breast cancer, and aromatase inhibitors such as letrozole and anastrozole, which are used to reduce estrogen levels in postmenopausal women. These treatments work by interfering with the hormone estrogen, which can promote the growth of breast cancer cells.

What other types of research exist?

Promising novel alternatives to Giredestrant for breast cancer patients in 2024 include: 1) Elacestrant, another selective estrogen receptor degrader (SERD) that has shown efficacy in clinical trials. 2) Oral selective estrogen receptor modulators (SERMs) like Lasofoxifene, which are being investigated for their potential benefits in hormone receptor-positive breast cancer. 3) CDK4/6 inhibitors such as Abemaciclib, which are used in combination with endocrine therapy to improve outcomes in advanced breast cancer. 4) PI3K inhibitors like Alpelisib, particularly for patients with PIK3CA-mutated breast cancer. These alternatives offer different mechanisms of action and can be considered based on individual patient profiles and specific cancer characteristics.

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Giredestrant + Phesgo for Breast Cancer

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Complete a minimum of four cycles of induction therapy

Achieve a minimum of stable disease (SD) (or Non-complete response [CR]/Non-progressive disease [PD] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase

Must not have

Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of giredestrant treatment in Arm B

Prior treatment with a selective estrogen receptor degrader (SERD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization for maintenance therapy to disease progression or death (up to 50 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a combination of two drugs is more effective than one drug for patients with advanced breast cancer. The drugs work by blocking signals that help cancer cells grow. The study focuses on patients whose cancer cannot be cured with surgery or other local treatments.

Who is the study for?

This trial is for adults with HER2-positive, ER-positive advanced breast cancer that can't be removed by surgery. They should have completed at least four cycles of induction therapy without disease progression and have a heart function (LVEF) ≥50%. Participants must not have had certain previous cancer treatments, uncontrolled health issues, or been pregnant or breastfeeding.

What is being tested?

The study compares the effectiveness and safety of Giredestrant combined with Phesgo versus Phesgo alone in patients after initial treatment with Phesgo plus taxane. It's a Phase III trial where participants are randomly assigned to one of two groups to see which treatment works better.

What are the potential side effects?

Possible side effects include reactions related to hormone therapies, infusion-related reactions from antibody drugs like those in Phesgo, and typical chemotherapy side effects such as fatigue, nausea, hair loss, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I have completed at least four cycles of initial cancer treatment.

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My cancer did not worsen after the initial treatment phase.

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My breast cancer is HER2 and ER positive and cannot be surgically removed.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I haven't taken strong CYP3A4 inhibitors or inducers in the last 14 days or longer.

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I have been treated with a SERD medication before.

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I haven't had major surgery or a serious injury in the last 14 days and don't expect to need major surgery soon.

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My high blood pressure is not well-managed.

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I have not exceeded the maximum safe doses of specific chemotherapy drugs.

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I have a serious liver condition or disease.

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I am not pregnant or breastfeeding and do not plan to become pregnant during the study or within 7 months after the last dose.

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I do not have active brain metastases or related conditions.

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I have been on daily steroids for more than 3 months.

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I have an active inflammatory bowel condition or have had major gut surgery.

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

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I haven't taken antibiotics for a serious infection in the last 7 days.

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I have a history of bleeding disorders or blood clots but they are now under control.

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I have long-lasting moderate to severe blood-related side effects from previous cancer treatments.

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I need oxygen all the time due to my advanced cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization for maintenance therapy to disease progression or death (up to 50 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization for maintenance therapy to disease progression or death (up to 50 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization for maintenance therapy to disease progression or death (up to 50 months) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

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

Objective Response Rate, as Determined by the Investigator According to RECIST v1.1

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Induction Therapy: Phesgo plus Taxane-Based ChemotherapyExperimental Treatment3 Interventions

Group II: Arm B, Maintenance Therapy: Giredestrant plus PhesgoExperimental Treatment3 Interventions

Group III: Arm A, Maintenance Therapy: PhesgoActive Control3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

LHRH Agonist

2013

Completed Phase 2

~130

Giredestrant

2019

Completed Phase 2

~300

Docetaxel

1995

Completed Phase 4

~6550

0 / 19Eligibility 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 pathways involved in cancer cell growth and survival. Selective Estrogen Receptor Degraders (SERDs) like Giredestrant work by binding to estrogen receptors on cancer cells, leading to receptor degradation and inhibition of estrogen-driven tumor growth. This is crucial for patients with hormone receptor-positive breast cancer. HER2-targeted therapies, such as trastuzumab and pertuzumab, bind to the HER2 protein on cancer cells, blocking signals that promote cell proliferation and survival. These treatments are vital for managing HER2-positive breast cancer, improving outcomes by specifically targeting the molecular drivers of the disease.