- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04294225
Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer
Pharmacodynamic Study of Estrogen Suppression Threshold-Directed Therapy (ESTDT) of Anastrozole as Adjuvant Therapy for Early Stage Breast Cancer
Study Overview
Status
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Invasive Breast Carcinoma
- Early-Stage Breast Carcinoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To estimate the proportion of women who have adequate estrone (E1) and estradiol (E2) suppression after 8-10 weeks of adjuvant anastrozole 10 mg once daily (ANA10) having had inadequate E1 and E2 suppression after 8-10 weeks of standard dose anastrozole 1 mg once daily (ANA1).
SECONDARY OBJECTIVES:
I. To estimate the proportion of women with elevated E1 and E2 levels after 8-10 weeks of adjuvant ANA1.
II. To estimate the proportion of women with elevated E1 and E2 levels after 8-10 weeks of adjuvant ANA1 whose E1 and E2 levels remain elevated after 8-10 weeks of adjuvant ANA10.
III. To examine the toxicity profile of ANA1 over the 8-10 weeks of treatment, ANA10 over the 8-10 weeks of treatment, and letrozole over the 8-10 weeks of treatment.
IV. To examine concentrations of anastrozole at both the ANA1 and ANA10 dose levels.
V. To examine E1 and E2 concentrations, as well as letrozole drug levels, in patients receiving letrozole (following ANA10).
VI. To bank deoxyribonucleic acid (DNA) for examination of single-nucleotide polymorphism (SNP)-set(s) determined in the ongoing Mayo Clinic Breast Cancer Specialized Program of Research Excellence (SPORE) Project 4.
EXPLORATORY OBJECTIVE:
I. To examine association between clinical variables such as age, age at menopause, body mass index (BMI), receipt of chemotherapy, chemotherapy regimen, and dose on E1 and E2 levels after 8-10 weeks of ANA10.
OUTLINE:
Patients receive anastrozole orally (PO) once daily (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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- REGISTRATION-INCLUSION CRITERIA
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)
- Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to registration)
- Platelet count >= 70,000/mm^3 (obtained =< 14 days prior to registration)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to registration)
- Ability to swallow oral medication
- Provide written informed consent
- Willingness to provide mandatory blood specimens for correlative research
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- RE-REGISTRATION-INCLUSION CRITERIA
- Confirmation that baseline blood sample was drawn and submitted
Blood estrogen levels after cycle 1 anastrozole (ANA1) must meet the following criteria:
- E1 >= 1.3 pg/ml, AND
- E2 >= 0.5 pg/ml
Exclusion Criteria:
- REGISTRATION-EXCLUSION CRITERIA
- 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])
- Prior ovarian function suppression (leuprolide, goserelin, etc.)
- Inability to provide informed consent
History of contralateral ductal carcinoma in situ (DCIS) or invasive breast cancer
NOTE: Exception allowed if
- Patient did not receive adjuvant endocrine therapy OR
- Patient received adjuvant endocrine therapy but has been off treatment for at least 6 months prior to registration
Concurrent active malignancy or history of malignancy =< 3 years prior to registration
- NOTE: Exceptions allowed for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, papillary thyroid cancer, or non-melanoma skin cancer
- Prior prevention therapy with an aromatase inhibitor or a selective estrogen receptor modulator (SERM). Exception: Therapy with a SERM (tamoxifen or raloxifene) is allowed if patient has been off treatment for >= 6 months prior to registration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (anastrozole, letrozole)
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.
|
Given PO
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 10 weeks
|
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
|
Up to 10 weeks
|
Estrogen suppression rate
Time Frame: Up to 10 weeks
|
Point and interval estimates for the estrogen suppression rate with anastrozole 10 mg daily for 8-10 weeks will be constructed using the properties of the binomial distribution.
|
Up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution of estrone (E1) and estradiol (E2) concentrations
Time Frame: After treatment of anastrozole 10 mg once daily and letrozole
|
Descriptive statistics will be used.
The percent change in E1 and E2 concentrations from pre-AI levels will be determined and graphically depicted using spider plots.
|
After treatment of anastrozole 10 mg once daily and letrozole
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tufia C Haddad, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Breast Neoplasms
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
- Anastrozole
Other Study ID Numbers
- MC1931 (Other Identifier: Mayo Clinic in Rochester)
- P30CA015083 (U.S. NIH Grant/Contract)
- P50CA116201 (U.S. NIH Grant/Contract)
- NCI-2020-01062 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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