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Hormone Therapy

Hormone Therapy + Chemotherapy for Breast Cancer (TAILORx Trial)

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

Must not have

Chronic obstructive pulmonary disease requiring treatment

Previous history of a cerebrovascular accident

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

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have had surgery for breast cancer.

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

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

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

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

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My tumor is not HER2 positive.

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I have a breast cancer tissue sample ready for testing.

Exclusion Criteria

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

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I am receiving treatment for chronic obstructive pulmonary disease.

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I have had a stroke before.

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I am a woman who can have children and am not using birth control.

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I have heart issues that prevent me from using certain cancer drugs.

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I have a long-term liver condition.

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, os 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, os 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, os rate estimated at 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

5-year Disease-free Survival

Secondary study objectives

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

Disease

5-year Distant Recurrence-free Interval

+3 more

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

2016

Completed Phase 4

~5550

Letrozole

2002

Completed Phase 4

~3590

Radiation Therapy

2017

Completed Phase 3

~7250

Tamoxifen Citrate

2011

Completed Phase 3

~3780

Exemestane

2003

Completed Phase 4

~7510

0 / 12Eligibility 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

395 Previous Clinical Trials

254,801 Total Patients Enrolled

54 Trials studying Breast Cancer

65,326 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)Lead Sponsor

13,842 Previous Clinical Trials

40,992,727 Total Patients Enrolled

945 Trials studying Breast Cancer

1,543,964 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

~529 spots leftby Sep 2025

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