NCT04294225

Brief Summary

This phase II trial studies how well anastrozole and letrozole after surgery work in treating patients with stage I-III breast cancer. Drugs, such as anastrozole and letrozole, may stop the growth of tumor cells by decreasing the amount of estrogen made by the body. Giving anastrozole and letrozole after surgery may prevent breast cancer from coming back (recurrence).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 28, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

February 26, 2020

Results QC Date

December 5, 2024

Last Update Submit

January 2, 2025

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Early-Stage Breast CarcinomaInvasive Breast CarcinomaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Adequate Estrogen Suppression After 8 Weeks of Adjuvant Anastrozole 10 mg Daily

    Percentage of women who have adequate E1 and E2 suppression (E1 \< 1.3 pg/ml and/or E2 \< 0.5) after 8-10 weeks of adjuvant anastrozole 10 mg daily having had inadequate E1 and E2 (E1 \>= 1.3 pg/ml and E2 \>= 0.5) after 8-10 weeks of adjuvant anastrozole 1 mg daily.

    24 weeks

Secondary Outcomes (2)

  • Number of Participants Experiencing a Grade 3 or Greater Adverse Event

    24 weeks

  • Percent Change in Estrone (E1) and Estradiol (E2) Concentrations

    24 weeks

Study Arms (1)

Treatment (anastrozole, letrozole)

EXPERIMENTAL

Patients receive anastrozole PO QD for 56-70 days (8-10 weeks). Patients with E1 \>= 1.3 pg/ml and E2 \>= 0.5 pg/ml continue to receive anastrozole PO QD for another 56-70 days (8-10 weeks). Patients then receive letrozole PO QD for 8-10 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: AnastrozoleDrug: Letrozole

Interventions

AnastrozoleDRUG

Given PO

Also known as: Anastrazole, Arimidex, ICI D1033, ICI-D1033, ZD-1033
Treatment (anastrozole, letrozole)
LetrozoleDRUG

Given PO

Also known as: CGS 20267, Femara
Treatment (anastrozole, letrozole)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Disease characteristics:
  • Histological confirmation of invasive breast carcinoma
  • Stage I-III breast cancer
  • Estrogen receptor (ER) positive disease according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as ER \>= 1% positive nuclear staining
  • Completion of all planned cancer treatments prior to registration:
  • Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)
  • Adjuvant radiation therapy, if needed
  • Neoadjuvant and/or adjuvant chemotherapy, if needed
  • Post-menopausal defined as
  • Age \>= 60 and amenorrhea \> 12 consecutive months OR
  • Previous bilateral oophorectomy OR
  • Age \< 60 and amenorrhea \> 12 consecutive months and documented follicle stimulating hormone (FSH) level within post-menopausal range according to institutional standard
  • NOTE: Patients who did not meet these criteria at time of diagnosis and received pre-operative (neoadjuvant) or post-operative (adjuvant) chemotherapy will not be allowed to participate
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to registration)
  • +12 more criteria

You may not qualify if:

  • Pre-menopausal women receiving ovarian function suppression (goserelin, leuprolide, etc.)
  • Stage IV (metastatic) breast cancer
  • HER2 positive breast cancer as defined by
  • HER2 immunohistochemistry (IHC) \>= 3+
  • HER2/CEP17 \>= 2.0
  • HER2/CEP17 \< 2.0 and average HER2 copy number of \>= 6.0 signals/cell
  • Prior endocrine therapy for this breast cancer. Exceptions:
  • Pre-operative aromatase therapy (anastrozole, letrozole, or exemestane) and last treatment was \>= 4 weeks prior to registration OR
  • Pre-operative tamoxifen therapy and last treatment was \>= 12 weeks prior to registration
  • Currently receiving any of the following cancer-directed therapies:
  • Radiation therapy
  • Systemic therapy such as chemotherapy (standard or investigational)
  • Bisphosphonate therapy started \< 4 weeks prior to registration
  • NOTE: If patient is currently on bisphosphonate therapy she must be on stable dose for \>= 4 weeks prior to registration. Patients not currently taking bisphosphonates will be allowed to start bisphosphonate therapy after completion of anastrozole (1 mg and 10 mg daily \[if given\]). Information regarding bisphosphonate therapy will be collected
  • Current use of systemic or topical exogenous estrogen or progesterone (menopausal hormone replacement therapy \[HRT\])
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AnastrozoleLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Tufia C Haddad MD
Organization
Mayo Clinic
Haddad.Tufia@mayo.edu
507/284-2511

Study Officials

  • Tufia C Haddad

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 4, 2020

Study Start

April 28, 2020

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

January 28, 2025

Results First Posted

January 28, 2025

Record last verified: 2023-10

Locations

US(3)