Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT04294225
Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer
A Phase 2 study testing Anastrozole and Letrozole in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Anastrozole and Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Apr 2020to 12 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Pharmacodynamic Study of Estrogen Suppression Threshold-Directed Therapy (ESTDT) of Anastrozole as Adjuvant Therapy for Early Stage Breast Cancer
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).
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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.
- 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
- Being tested
- Anastrozole, Letrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Anastrazole, Arimidex, ICI D1033, ICI-D1033
Given PO
LetrozoleDrug
Also called CGS 20267, Femara
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anastrozole; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (2)
Number of Participants Experiencing a Grade 3 or Greater Adverse Event
Patients will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Patients were to receive anastrozole 1 mg daily for 8 weeks (ANA1). After 8 weeks of ANA1, patients with E1 < 1.3 pg/ml and/or E2 < 0.5 pg/ml completed study and patients with E1 >= 1.3 pg/ml and E2 >= 0.5 pg/ml were to switch to anastrozole 10 mg daily (ANA10) for 8 weeks. After 8 weeks of ANA10, patients were to switch to letrozole 2.5 mg daily for 8 weeks. E1 and E2 levels were measured after this 8 week period. Patients were then go off study
Measured: 24 weeks
Percent Change in Estrone (E1) and Estradiol (E2) Concentrations
Descriptive statistics will be used. The median percent change in E1 and E2 concentrations from pre-AI levels will be presented.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start28 Apr 2020
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tufia C Haddad, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294225
- Sponsor's protocol ID
- MC1931
- Other IDs
- NCI-2020-01062, MC1931, P30CA015083, P50CA116201
- Status last verified
- Oct 2023
- First submitted
- 26 Feb 2020
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Study of Estrogen Suppression Threshold-Directed Therapy (ESTDT) of Anastrozole as Adjuvant Therapy for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04294225
- Acronym / sponsor ID
- MC1931
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (anastrozole, letrozole) | Experimental | Drug: Anastrozole, Drug: LetrozolePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- REGISTRATION-INCLUSION CRITERIA
- Disease characteristics:
- Completion of all planned cancer treatments prior to registration:
- Post-menopausal defined as
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Key exclusion criteria (25 listed)
- 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
- Prior endocrine therapy for this breast cancer. Exceptions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnastrozoleAlso: Anastrazole, Arimidex, ICI D1033, ICI-D1033Given PO | Drug | Treatment (anastrozole, letrozole) |
| LetrozoleAlso: CGS 20267, FemaraGiven PO | Drug | Treatment (anastrozole, letrozole) |
Primary outcome
Percentage of Participants With Adequate Estrogen Suppression After 8 Weeks of Adjuvant Anastrozole 10 mg Daily
Time frame: 24 weeks
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.
2 secondary outcomes
Number of Participants Experiencing a Grade 3 or Greater Adverse Event
Time frame: 24 weeks
Percent Change in Estrone (E1) and Estradiol (E2) Concentrations
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tufia C Haddad principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anastrozole and Letrozole in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adequate Estrogen Suppression After 8 Weeks of Adjuvant Anastrozole 10 mg Daily (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.