Quality-of-Life Assessment for Estrogen Receptor Positive Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Estrogen Receptor Positive Breast Cancer+7 MoreQuality-of-Life Assessment - Other
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether suppressing ovarian function and combining it with either tamoxifen or exemestane is more effective than tamoxifen alone in treating premenopausal women with hormone-responsive breast cancer.

Eligible Conditions
  • Estrogen Receptor Positive Breast Cancer
  • Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IB Breast Cancer
  • Stage IIA Breast Cancer
  • Progesterone Receptor Positive Tumor
  • Stage IA Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 8-year estimates, reported at a median follow-up of 8 years

Month 67
Breast Cancer-free Interval
Disease-free Survival
Distant Recurrence-free Interval
Year 8
Overall Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Tamoxifen
1 of 3
T+OFS
1 of 3
E+OFS
1 of 3

Active Control

Experimental Treatment

3066 Total Participants · 3 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 3

T+OFSExperimental Group · 6 Interventions: Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Radiation Therapy, Tamoxifen, Triptorelin · Intervention Types: Other, Procedure, Other, Radiation, Drug, Drug
E+OFSExperimental Group · 6 Interventions: Exemestane, Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Radiation Therapy, Triptorelin · Intervention Types: Drug, Other, Procedure, Other, Radiation, Drug
TamoxifenActiveComparator Group · 3 Interventions: Laboratory Biomarker Analysis, Quality-of-Life Assessment, Tamoxifen · Intervention Types: Other, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exemestane
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Tamoxifen
FDA approved
Tryptophan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8-year estimates, reported at a median follow-up of 8 years

Who is running the clinical trial?

International Breast Cancer Study GroupLead Sponsor
28 Previous Clinical Trials
22,052 Total Patients Enrolled
ETOP IBCSG Partners FoundationLead Sponsor
60 Previous Clinical Trials
54,594 Total Patients Enrolled
NSABP Foundation IncNETWORK
86 Previous Clinical Trials
133,936 Total Patients Enrolled
Breast International GroupOTHER
33 Previous Clinical Trials
51,880 Total Patients Enrolled
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
114,922 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,125,789 Total Patients Enrolled
NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
141,775 Total Patients Enrolled
Southwest Oncology GroupNETWORK
386 Previous Clinical Trials
258,587 Total Patients Enrolled
North Central Cancer Treatment GroupNETWORK
48 Previous Clinical Trials
78,066 Total Patients Enrolled
Gini FlemingPrincipal InvestigatorETOP IBCSG Partners Foundation
3 Previous Clinical Trials
164 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
For the centers in the International Breast Cancer Study Groups (IBCSG), the patients must have completed the baseline Quality of Life (QL) Forms prior to the randomization; the only exceptions are the cognitive or physical impairment that interferes with the QL assessment or the inability to read any of the languages available on the IBCSG QL forms
Patients who receive prior adjuvant and/or neoadjuvant chemotherapy should be randomized around 8 months after their final dose of chemotherapy
, for the adjuvant treatment of patients with early stage HER2-positive breast cancer
Patients must have hormone receptor positive tumors; if there is more than one breast tumor, each tumor must be hormone receptor positive; the tumors must be determined using immunohistochemistry; estrogen receptor (ER) and/or progesterone receptor (PgR) must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation; biochemical determination alone is not acceptable.
Either an axillary lymph node dissection or a negative axillary sentinel node biopsy is required
This text is explaining that in order to quality control measures for a protocol, resected breast cancer pathology material should be available for submission for central review.
Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception.
If a woman has temporary chemotherapy-induced amenorrhea and regains premenopausal status within eight months of the final dose of chemotherapy, she is eligible to participate in the study
References