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Hormone Therapy

Fulvestrant + Anastrozole for Breast Cancer

Q: How many participants are being taken into this research project?

This particular clinical trial is no longer looking for new participants. However, if you are interested in other trials, 4702 different studies are actively enrolling patients with <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> and 189 studies for Arm III (anastrozole and fulvestrant) are also searching for new patients.

Q: Is this study also being conducted in other countries besides North America?

At the moment, the trial is running at 100 locations, which are situated in Centralia, Clackamas, Selinsgrove, and other areas. If you want to reduce the amount of travel required, it would be best to pick a location near you.

Q: How is Arm III (anastrozole and fulvestrant) most often employed?

Arm III, which is a combination of anastrozole and fulvestrant, is most commonly used to treat the brca1 gene. However, it is also used off-label to treat conditions such as <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, malignant neoplasms, and the pik3ca gene mutation.

Q: Is there a high chance of serious side effects from Arm III (anastrozole and fulvestrant)?

Arm III, which is anastrozole and fulvestrant, is considered safe by our team at Power. This is because it is a Phase 3 trial, indicating that efficacy has been supported by some data and safety has been supported by multiple rounds of data.

Q: Could you please provide some clarity on Arm III (anastrozole and fulvestrant) and any other relevant research?

There are a total of 189 active clinical trials worldwide for the Arm III (anastrozole and fulvestrant) medication. Of these 189 trials, 49 are in Phase 3. Most Arm III (anastrozole and fulvestrant) studies are conducted in Correggio, RE; however, there are 11777 locations where Arm III (anastrozole and fulvestrant) studies are taking place.

Q: Are there any current openings for people who wish to participate in this research?

This trial is no longer recruiting patients. The original posting date was December 13, 2013, and the last update was on August 2, 2022. There are currently 4702 trials actively recruiting patients with <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> and 189 trials for Arm III (anastrozole and fulvestrant) that are actively enrolling patients.

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Postmenopausal, verified by: post bilateral surgical oophorectomy or no spontaneous menses ≥ 1 year or no menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant is better than anastrozole when given before surgery to shrink the cancer and stop it from growing.

Who is the study for?

Postmenopausal women with Stage II-III estrogen receptor positive breast cancer, who have not started any treatment and are planning to undergo surgery. Participants must be at least 18 years old, have a specific score indicating the presence of estrogen receptors in their tumor cells, and meet certain health criteria based on blood tests and physical exams.Check my eligibility

What is being tested?

The trial is testing whether taking fulvestrant alone or combined with anastrozole before surgery is more effective than just anastrozole for shrinking tumors. Anastrozole lowers estrogen to inhibit tumor growth and is standard care pre-surgery; fulvestrant decreases estrogen receptors in tumor cells but isn't approved for early-stage use yet.See study design

What are the potential side effects?

Possible side effects include hot flashes, joint pain, nausea, fatigue, bone weakness or loss (osteoporosis), mood changes, vaginal dryness or bleeding. Fulvestrant may also cause injection site reactions such as pain or inflammation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am able to care for myself and perform daily activities.

Select...

I am postmenopausal, confirmed by surgery, lack of periods for a year or hormone levels.

Select...

My breast cancer is at a stage where surgery is aimed to remove the tumor and it can be felt or measured to be at least 2cm.

Select...

My breast cancer was confirmed with a needle biopsy.

Select...

I am a woman aged 18 or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic complete response rate-(pCR rate)

Rate of endocrine resistant disease-(First Phase)

Recurrence-free survival (RFS)-(Second Phase)

Trial Design

3Treatment groups

Active Control

Group I: Arm III (anastrozole and fulvestrant)Active Control2 Interventions

Patients receive anastrozole daily in combination with fulvestrant on days 1 and 15 of cycle 1, and on day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Group II: Arm I (anastrozole)Active Control1 Intervention

Patients receive anastrozole daily for 6 cycles followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Group III: Arm II (fulvestrant)Active Control1 Intervention

Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

216,165 Total Patients Enrolled

75 Trials studying Breast Cancer

40,143 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,931,680 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Cynthia Ma, MD, PhDStudy ChairWashington University School of Medicine

1 Previous Clinical Trials

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01953588 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being taken into this research project?

"This particular clinical trial is no longer looking for new participants. However, if you are interested in other trials, 4702 different studies are actively enrolling patients with breast cancer and 189 studies for Arm III (anastrozole and fulvestrant) are also searching for new patients."

Answered by AI

Is this study also being conducted in other countries besides North America?

"At the moment, the trial is running at 100 locations, which are situated in Centralia, Clackamas, Selinsgrove, and other areas. If you want to reduce the amount of travel required, it would be best to pick a location near you."

Answered by AI

How is Arm III (anastrozole and fulvestrant) most often employed?

"Arm III, which is a combination of anastrozole and fulvestrant, is most commonly used to treat the brca1 gene. However, it is also used off-label to treat conditions such as breast cancer, malignant neoplasms, and the pik3ca gene mutation."

Answered by AI

Is there a high chance of serious side effects from Arm III (anastrozole and fulvestrant)?

"Arm III, which is anastrozole and fulvestrant, is considered safe by our team at Power. This is because it is a Phase 3 trial, indicating that efficacy has been supported by some data and safety has been supported by multiple rounds of data."

Answered by AI

Could you please provide some clarity on Arm III (anastrozole and fulvestrant) and any other relevant research?

"There are a total of 189 active clinical trials worldwide for the Arm III (anastrozole and fulvestrant) medication. Of these 189 trials, 49 are in Phase 3. Most Arm III (anastrozole and fulvestrant) studies are conducted in Correggio, RE; however, there are 11777 locations where Arm III (anastrozole and fulvestrant) studies are taking place."

Answered by AI

Are there any current openings for people who wish to participate in this research?

"This trial is no longer recruiting patients. The original posting date was December 13, 2013, and the last update was on August 2, 2022. There are currently 4702 trials actively recruiting patients with breast cancer and 189 trials for Arm III (anastrozole and fulvestrant) that are actively enrolling patients."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results from the American College of Surgeons Oncology Group Z1031 Trial (alliance)

Ellis, Matthew J., Vera J. Suman, Jeremy Hoog, Rodrigo Goncalves, Souzan Sanati, Chad J. Creighton, Katherine DeSchryver, et al.. 2017. “Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results from the American College of Surgeons Oncology Group Z1031 Trial (alliance)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2016.69.4406.

clinicaltrials.govStudy

Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

2013. "Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01953588.

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