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Breast

A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

Unique Dataset IDBreast_Allianc_2006_216
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients622Comparator (Control) Arm Enrolled Patients0Experimental (Active) Arm Enrolled Patients377RandomizationYesClinicalTrial.gov IDNCT00265759ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/record/NCT00265759?term=Z1031&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeDrug, SurgeryDataset TypeADS

Clinical Trial Title

A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

Trial Summary and Conditions

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.

Data Summary

Experimental arm data files include data on safety, efficacy, demographics, etc. See the data dictionary for complete details.

Study Objectives

Primary: To determine whether anastrozole, exemestane or letrozole administered for 16 to 18 weeks as neoadjuvant endocrine treatment for postmenopausal patients with stage II or stage III ER+ breast cancer should be chosen as the aromatase inhibitor arm of a future study that will compare neoadjuvant aromatase inhibitor treatment with neoadjuvant chemotherapy. Secondary: To compare the neoadjuvant treatment regimens relative to the rates of improvement in surgical outcome. To compare and confirm the radiological response rates (mammography by central radiological analysis) between these three neoadjuvant treatment regimens. To compare the relative safety of the neoadjuvant treatment regimens in terms of reported adverse events. See protocol for further details.

Outcome Measures

Clinical Response (Complete or Partial Response) Rate (Cohort A) [ Time Frame: Up to 18 weeks ] The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Z1031Prot_06Apr2015.pdf

CRF: Z1031 A7 CRFS 08-09-10.pdf

DATA DICTIONARY: z1031_datadictionary.docx

DATA (ACTIVE ARM): NCT00265759.csv