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Hormone Therapy

Hormone Therapy + Chemotherapy for Breast Cancer (TAILORx Trial)

Q: Are individuals aged 55 or older able to enroll in this trial?

According to the research parameters set forth by this study, any individual aged 18-75 is eligible to participate.

Q: What indications are usually seen for Radiation Therapy?

Radiation therapy is a standard treatment for malignant neoplasms, but it can also help manage other conditions like <a href="https://www.withpower.com/clinical-trials/ovarian-cancer">ovarian cancer</a>, tamoxifen, and high risk.

Q: How many people are allowed to participate in this trial at any given time?

This study is not recruiting patients at this moment. The clinical trial was first posted on April 7th, 2006 and edited for the last time on October 29th, 2022. For individuals who are interested in other studies, there are 2372 trials actively searching for <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> patients and 235 studies for Radiation Therapy that need participants.

Q: Does this form of treatment have a history?

As of right now, 235 clinical trials are underway that focus on Radiation Therapy. Out of these, 67 have reached Phase 3 status. The majority of the research is being conducted in Shanghai but there are 16108 total locations registered as running studies for Radiation Therapy.

Phase 3

Waitlist Available

Led By Joseph A Sparano

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment

ER and/or progesterone receptor (PR)-positive disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 6 months within 5 years from registration and then annually up to 20 years

Awards & highlights

TAILORx Trial Summary

This trial is studying the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer.

Who is the study for?

This trial is for women with node-negative, estrogen-receptor positive breast cancer who have had surgery. They should expect to live at least 10 years and not have received prior radiation or chemotherapy for this cancer. Participants must not be pregnant, breastfeeding, or have serious health issues like heart failure or chronic liver disease.Check my eligibility

What is being tested?

The study tests if hormone therapy alone or combined with chemotherapy is more effective in women with certain Oncotype DX recurrence scores. It examines the role of estrogen in tumor cell growth and whether blocking it or reducing its production can better prevent cancer recurrence.See study design

What are the potential side effects?

Hormone therapy may cause hot flashes, fatigue, joint pain, and risk of blood clots. Chemotherapy could lead to hair loss, nausea, increased infection risk due to low blood counts, mouth sores, and potential damage to the heart.

TAILORx Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had surgery for breast cancer.

Select...

My cancer is positive for estrogen and/or progesterone receptors.

Select...

I have had surgery that meets the trial's requirements.

Select...

I haven't had chemotherapy or radiation for my cancer.

Select...

My tumor is between 5 mm and 5 cm, possibly with aggressive features.

Select...

My tumor is not HER2 positive.

Select...

I have a breast cancer tissue sample ready for testing.

TAILORx Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 6 months within 5 years from registration and then annually up to 20 years, rfs rate estimated at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 6 months within 5 years from registration and then annually up to 20 years, rfs rate estimated at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 6 months within 5 years from registration and then annually up to 20 years, rfs rate estimated at 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

5-year Disease-free Survival

Secondary outcome measures

5-year Disease-free Survival by Age and Recurrence Score Groups

Disease

5-year Distant Recurrence-free Interval

+3 more

TAILORx Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group 3 (Oncotype DX recurrence score >= 26)Experimental Treatment7 Interventions

Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in group two who are assigned to receive both types of treatment.

Group II: Group 2, Arm I (experimental)Experimental Treatment6 Interventions

Patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.

Group III: Group 1 (Oncotype DX recurrence score =< 10)Experimental Treatment7 Interventions

Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.

Group IV: Group 2, Arm II (standard)Active Control7 Interventions

Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

2019

Completed Phase 4

~10090

Letrozole

2002

Completed Phase 4

~3240

Radiation Therapy

2017

Completed Phase 3

~7250

Tamoxifen Citrate

2011

Completed Phase 3

~3750

Exemestane

2003

Completed Phase 4

~7880

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cancer and Leukemia Group BNETWORK

80 Previous Clinical Trials

107,715 Total Patients Enrolled

20 Trials studying Breast Cancer

30,776 Patients Enrolled for Breast Cancer

SWOG Cancer Research NetworkNETWORK

394 Previous Clinical Trials

254,897 Total Patients Enrolled

54 Trials studying Breast Cancer

65,326 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,922,880 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00310180 — Phase 3

Breast Cancer Research Study Groups: Group 2, Arm I (experimental), Group 3 (Oncotype DX recurrence score >= 26), Group 1 (Oncotype DX recurrence score =< 10), Group 2, Arm II (standard)

Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT00310180 — Phase 3

Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00310180 — Phase 3

Frequently Asked Questions

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

Are individuals aged 55 or older able to enroll in this trial?

"According to the research parameters set forth by this study, any individual aged 18-75 is eligible to participate."

Answered by AI

What indications are usually seen for Radiation Therapy?

"Radiation therapy is a standard treatment for malignant neoplasms, but it can also help manage other conditions like ovarian cancer, tamoxifen, and high risk."

Answered by AI

How many people are allowed to participate in this trial at any given time?

"This study is not recruiting patients at this moment. The clinical trial was first posted on April 7th, 2006 and edited for the last time on October 29th, 2022. For individuals who are interested in other studies, there are 2372 trials actively searching for breast cancer patients and 235 studies for Radiation Therapy that need participants."

Answered by AI

Does this form of treatment have a history?

"As of right now, 235 clinical trials are underway that focus on Radiation Therapy. Out of these, 67 have reached Phase 3 status. The majority of the research is being conducted in Shanghai but there are 16108 total locations registered as running studies for Radiation Therapy."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Patient-reported Cognitive Impairment Among Women with Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results from Tailorx

Wagner, Lynne I., Robert J. Gray, Joseph A. Sparano, Timothy J. Whelan, Sofia F. Garcia, Betina Yanez, Amye J. Tevaarwerk, et al.. 2020. “Patient-reported Cognitive Impairment Among Women with Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results from Tailorx”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.01866.

New England Journal of MedicineJournal

Adjuvant Chemotherapy Guided by a 21-gene Expression Assay in Breast Cancer

Sparano, Joseph A., Robert J. Gray, Della F. Makower, Kathleen I. Pritchard, Kathy S. Albain, Daniel F. Hayes, Charles E. Geyer Jr., et al.. 2018. “Adjuvant Chemotherapy Guided by a 21-gene Expression Assay in Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1804710.

JAMA OncologyJournal

Association of Modifiable Risk Factors with Early Discontinuation of Adjuvant Endocrine Therapy

Yanez, Betina, Robert J. Gray, Joseph A. Sparano, Ruth C. Carlos, Gelareh Sadigh, Sofia F. Garcia, Ilana F. Gareen, et al.. 2021. “Association of Modifiable Risk Factors with Early Discontinuation of Adjuvant Endocrine Therapy”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2021.1693.

Clinical TrialsJournal