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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
No Placebo-Only Group
Pivotal 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.
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 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

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

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
~3880
Exemestane
2003
Completed Phase 4
~7510

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
398 Previous Clinical Trials
255,343 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,101,844 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
249,928 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
NSABP Foundation IncNETWORK
88 Previous Clinical Trials
130,029 Total Patients Enrolled
46 Trials studying Breast Cancer
102,330 Patients Enrolled for Breast Cancer
American College of SurgeonsOTHER
16 Previous Clinical Trials
50,012 Total Patients Enrolled
2 Trials studying Breast Cancer
3,202 Patients Enrolled for Breast Cancer
North Central Cancer Treatment GroupNETWORK
48 Previous Clinical Trials
70,859 Total Patients Enrolled
18 Trials studying Breast Cancer
39,753 Patients Enrolled for Breast Cancer
NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
134,568 Total Patients Enrolled
30 Trials studying Breast Cancer
40,737 Patients Enrolled for Breast Cancer
Joseph A SparanoPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
35 Total Patients Enrolled

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
~522 spots leftby Dec 2025
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