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Breast CancerPhase 2BabyTEARSNCT07499999

Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer

A Phase 2 study testing Exemestane and Tamoxifen in people with Breast Cancer and Ductal Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer. The names of the study drugs involved in this study are: Exemestane (a type of steroidal aromatase inhibitor) Tamoxifen (a type of selective… Read more about this study

Who is it for?
Any age, women only
What is being tested?
Exemestane and Tamoxifen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesUnited States
Study dates
9 Sep 2026to 31 Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Postmenopausal state is defined⁸ as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.
  • Any of the following criteria must be met:
  • Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (>5%) DCIS (patients with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy (see footnote 1 below)) diagnosis within 3 years of HRL (ADH, LCIS, ALH), or;
  • At least 3% breast cancer risk at 5 years (or 5% risk at 10yrs) per one of the following risk models: the Breast Cancer Surveillance Consortium risk calculator V3 or Tyrer-Cuzick model V8 or;
  • Known carriers of a germline pathogenic/likely pathogenetic variant in the following moderate penetrance genes (CHEK2 or ATM), or women with chest wall irradiation before age of 30 years
  • Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1
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  • Able to swallow oral medications
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Specifically, all cancers diagnosed since 3 years or longer except for breast and endometrial are eligible.
  • Ability to understand and the willingness to sign a written informed consent document
  • Mammography performed up to 6 months before the trial consent form signature
  • DEXA performed up to 12 months before the trial consent form signature
  • Life expectancy ≥ 10 years
  • Normal liver function tests and blood cell count
  • Negative gynecological examination performed up to 6 months before the trial consent form signature.
  • ᶥ While DCIS and ADH are routinely excised, and treatment of DCIS often includes radiotherapy, lobular neoplasia (ALH and classic LCIS) are not routinely excised in most US centers unless radiologic-pathologic findings are discordant given the very low risk of an associated cancer.11,12 Participants with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy. All DCIS will require excision to clear margins per the SSO/ASCO/ASTRO margin guidelines for DCIS.88 In selected cases, the decision to omit RT might be taken according to low risk clinical-pathological factors (e.g., age>70, low grade, size < 1 cm, and genomic assays if available) as well as patient preference after full discussion of the risks and benefits.
  • Only women will be recruited in the study given that breast cancer is much more frequent in women than men and because exemestane is contraindicated in men because of risk of uncontrolled gonadal stimulation. Women of all races and ethnic groups are eligible for this trial. At participating sites, efforts will be made to enroll women from diverse ethnic and socio-economic backgrounds, including recruitment of non-white women in a selected New York city area.
  • NIH policy requires that women and members of minority groups and their subpopulations be included in all NIH-supported biomedical and behavioral research projects involving NIH-defined clinical research unless a clear and compelling rationale and justification establishes to the satisfaction of the funding Institute \& Center (IC) Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances designated by the Director, NIH, upon the recommendation of an IC Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research.

Who cannot join

  • Pre/perimenopausal women: exemestane is only effective in post-menopausal women
  • History of DVT or PE: tamoxifen can increase tendency to blood clot
  • Endometrial cancer: full-dose tamoxifen is associated with increased risk of endometrial cancers
  • Macular disorders: tamoxifen is associated with retinal damage
  • Inability to comply with study procedures: standard
  • Prior use of antiestrogens within 12 months from the date of the trial consent form signature: there can be long duration effects from antiestrogens that could influence trial drug effects
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  • Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature: similarly, wish to avoid any long lasting effect before alternate effect from study drugs
  • Severe osteoporosis (T score ≤ 2.5 at either spine or hip), or recent vertebral fracture (within 6 months) not treated with zoledronic acid or denosumab: Exemestane is an aromatase inhibitor which can worsen bone loss (osteoporosis)
  • Current use of terbinafine, quinidine, cinacalcet, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort, warfarin, erythromycin, cyclosporin, nifedipine and any concomitant coumarin-type anti-coagulant therapy: these drugs compete for the Cytochrome P450 metabolic pathways of tamoxifen and exemestane
  • Moderate or severe renal impairment: Exemestane is eliminated equally by liver and renal metabolism
  • Known hypersensitivity to study drugs: standard
  • Screening Eligibility Criteria
  • To register a participant to the screening phase, the following documents should be provided by the participating site:
  • Signed participant consent form
  • Postmenopausal status, and any of the following:
  • Histological report of ER-positive DCIS within 12 months, or HRL of the breast within 3 years from date of consent form signature, or;
  • Report of risk assessment ≥3% in 5 years or 5% in 10 years of breast cancer according to the selected risk model(s) different criteria within 6 months from screening, or;
  • Documentation of women carriers of a germline pathogenic/likely pathogenetic variant in a moderate penetrance gene (CHEK2 or ATM), or;
  • Documented history of chest wall radiotherapy before age 30.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Judy Garber, MD, MPH contact

617-632-2282

judy_garber@dfciharvard.edu

Judy Garber, MD. MPH contact

617-582-8321

judy_garber@dfciharvard.edu

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Judy Garber, MD, MPH, 617-632-2282, judy_garber@dfciharvard.edu

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Judy Garber, MD. MPH, 617-632-2282, judy_garber@dfciharvard.edu

    Judy Garber, MD. MPH, 617-632- 2282, judy_garber@dfciharvard.edu

Other trials in United States

About this study

Official title: Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer (BabyTEARS)

The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer.

The names of the study drugs involved in this study are:

  • Exemestane (a type of steroidal aromatase inhibitor)
  • Tamoxifen (a type of selective estrogen receptor modulator)
Read the detailed description

This randomized, double-blind, phase II trial is to evaluate the efficacy and safety of low-dose "baby" exemestane versus low-dose "baby" tamoxifen in post-menopausal women at high risk for breast cancer. Both medications are used at full doses for breast cancer treatment and to reduce breast cancer risk. Low dose tamoxifen has been shown to be effective at reducing risk with better tolerance.

Participants will be randomized into one of two study groups: Group A: Exemestane versus Group B: Tamoxifen. Randomization means a participant is placed into a study group by chance. Neither a participant or the research doctor will choose or know what group a participant is placed in. This is called a "double-blind".

The U.S. Food and Drug Administration (FDA) has not approved tamoxifen or exemestane for ER+ DCIS, High Risk Lesions, or being at high-risk for breast cancer but it has been approved for other uses.

The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, Mammography scans, and bone density (DEXA) scans.

Participation in this research study is expected to last about 12 months. It is expected that about 140 people will take part in this research study. The Breast Cancer Research Foundation is supporting this research study by providing funding. MRIGlobal is providing support by supplying the study drugs.

Being tested
Exemestane, Tamoxifen
Keywords
Breast Cancer, High Risk Breast Cancer, Cancer Prevention, Ductual Carcinoma in Site, Estrogen Receptor Positive, High Risk Lesions, HRL, Atypical Lobular Hyperplasia, BRCA2, CHEK2, ATM
Medical subject headings
Breast Neoplasms, Carcinoma, Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExemestaneDrug

    Also called C20H24O2

    A steroidal aromatase inhibitor, blinded capsules taken orally, per protocol.

  • TamoxifenDrug

    Also called C32H37NO8

    A selective estrogen receptor modulator, blinded capsules taken orally, per protocol.

Study groups in NCT07499999
Study groupRoleWhat they receive
Low-Dose ExemestaneExperimentalParticipants will be randomized 1:1 with a permuted-block technique and stratified by center and will complete: * Baseline visit with assessments * Predetermined dose of Exemestane 1x on every odd day for 12 months * 3 month in-clinic visit * 6 month in-clinic visit * 9 month in-clinic visit * 12 month end of intervention in-clinic visit * Follow up for 12 months
Receives: Drug: Exemestane
Low-Dose TamoxifenExperimentalParticipants will be randomized 1:1 with a permuted-block technique and stratified by center and will complete: * Baseline visit with assessments * Predetermined dose of Tamoxifen 1x on every odd day for 12 months * 3 month in-clinic visit * 6 month in-clinic visit * 9 month in-clinic visit * 12 month end of intervention in-clinic visit * Follow up for 12 months
Receives: Drug: Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months

    The MENQOL assesses the degree to which menopausal symptoms are troublesome in four domains: vasomotor (three items), sexual (three items), physical (seven items), and psychosocial (16 items). Each item is answered with Yes or No. If the response is Yes, the participant rates how bothersome the symptom was on a scale from 0 to 6, where 0 indicates "not at all bothered" and 6 indicates "extremely bothered." For each participant, the difference between the baseline and 12-month overall MENQOL score will be calculated and defined as the "change."

    Measured: 12 Months

Secondary outcomes (21)

  1. Difference of Free Estradiol Levels between Two Arms at 12 Months

    Free estradiol concentration in blood will be measured to compare the hormonal effects of babyexe versus babytam.

    Measured: 12 Months

  2. Difference of Estradiol/Sex Hormone Binding Globulin (SHBG) Levels between Two Arms at 12 Months

    The estradiol/SHBG ratio will be calculated as total estradiol divided by SHBG to evaluate differences in hormonal effects between babyexe and babytam.

    Measured: 12 Months

  3. Difference of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Levels Between Two Arms at 12 Months

    Blood levels of IGF-I will be measured to compare the effects of babyexe and babytam on IGF-I.

    Measured: 12 Months

  4. Insulin-like Growth Factor I (IGF-I)/Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Ratio Between Two Arms at 12 Months

    The ratio of IGF-I to IGFBP-3 in blood will be calculated to compare the effects of babyexe and babytam on IGF system balance.

    Measured: 12 Months

  5. Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) at 6 Months

    The MENQOL assesses the degree to which menopausal symptoms are troublesome in four domains: vasomotor (three items), sexual (three items), physical (seven items), and psychosocial (16 items). Each item is answered with Yes or No. If the response is Yes, the participant rates how bothersome the symptom was on a scale from 0 to 6, where 0 indicates "not at all bothered" and 6 indicates "extremely bothered." For each participant, the difference between the baseline and 6-month overall MENQOL score will be calculated and defined as the "change."

    Measured: 6 months

  6. Free Estradiol Levels

    Free estradiol concentration in blood will be measured to compare the hormonal effects of babyexe versus babytam.

    Measured: 6 Months

  7. Estradiol/Sex Hormone Binding Globulin (SHBG) Levels

    The estradiol/SHBG ratio will be calculated as total estradiol divided by SHBG to evaluate differences in hormonal effects between babyexe and babytam.

    Measured: 6 months

  8. Insulin-like Growth Factor I (IGF-I) Levels

    Blood levels of IGF-I will be measured to compare the effects of babyexe and babytam on IGF-I.

    Measured: 6 months

  9. Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Levels

    Blood levels of IGFBP-3 will be measured to compare the effects of babyexe and babytam on IGFBP-3.

    Measured: 6 months

  10. Insulin-like Growth Factor I (IGF-I)/Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Ratio

    The ratio of IGF-I to IGFBP-3 in blood will be calculated to compare the effects of babyexe and babytam on IGF system balance.

    Measured: 6 months

  11. Physical Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 6 Months and 12 months

    The MENQOL physical domain, which includes seven items, assesses the degree to which physical menopausal symptoms are troublesome. Each item is answered with Yes or No. If the response is Yes, the participant rates how bothersome the symptom was on a scale from 0 ("not at all bothered") to 6 ("extremely bothered"). For each participant, the difference between the baseline and 6-month physical domain MENQOL score will be calculated and defined as the "change."

    Measured: 6 months and 12 months

  12. Sexual Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL)

    The MENQOL sexual domain, which includes three items, assesses the degree to which sexual menopausal symptoms are troublesome. Each item is answered with Yes or No. If the response is Yes, the participant rates how bothersome the symptom was on a scale from 0 ("not at all bothered") to 6 ("extremely bothered"). For each participant, the difference between the baseline and 6-month sexual domain MENQOL score will be calculated and defined as the "change."

    Measured: 6 months and 12 months

  13. Psychosocial Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL)

    The MENQOL psychosocial domain, which includes sixteen items, assesses the degree to which psychosocial menopausal symptoms are troublesome. Each item is answered with Yes or No. If the response is Yes, the participant rates how bothersome the symptom was on a scale from 0 ("not at all bothered") to 6 ("extremely bothered"). For each participant, the difference between the baseline and 6-month psychosocial domain MENQOL score will be calculated and defined as the "change."

    Measured: 6 months and 12 months

  14. Vasomotor Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL)

    The MENQOL vasomotor domain, which includes three items, assesses the degree to which vasomotor menopausal symptoms are troublesome. Each item is answered with Yes or No. If the response is Yes, the participant rates how bothersome the symptom was on a scale from 0 ("not at all bothered") to 6 ("extremely bothered"). For each participant, the difference between the baseline and 6-month vasomotor domain MENQOL score will be calculated and defined as the "change."

    Measured: 6 months and 12 months

  15. Global Adverse Event (AE) Rate

    Global AE rate is defined as the proportion of participants who experience any AE. AE is summarized and graded based on CTCAE v 5.0.

    Measured: 12 Months

  16. Grade 2 or Higher Adverse Event (AE) Rate

    Grade 2 or higher AE rate is defined as the proportion of participants who experience grade 2 or higher AE. AE is summarized and graded based on CTCAE v 5.0.

    Measured: 12 months

  17. Grade 3 or Higher Adverse Event (AE) Rate

    Grade 3 or higher AE rate is defined as the proportion of participants who experience grade 2 or higher AE. AE is summarized and graded based on CTCAE v 5.0.

    Measured: 12 months

  18. Distribution of Maximum Adverse Event Grade per Participant

    The maximum adverse event (AE) grade experienced by each participant during the treatment period will be summarized to characterize the overall toxicity profile. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. For each participant, the highest AE grade observed at any time during the treatment period will be identified, and the distribution of these maximum grades across participants will be reported, in accordance with the statistical considerations for toxicity evaluation described in Section 16.15 of the protocol.

    Measured: 12 months

  19. Medication Adherence Assessed by PMAS

    Medication adherence will be assessed using the PMAS instrument, as specified in Appendix H of the protocol. PMAS is a validated wording-based adherence scale and does not generate a continuous numeric summary score. Therefore, adherence will be operationalized categorically, consistent with its original validation methodology. Participants will be classified into predefined adherence categories based on their item responses (e.g., high adherence versus non-high adherence). Adherence will be summarized as the proportion of participants meeting the definition of "high adherence" within each treatment arm. Between-arm comparisons will be based on categorical distributions rather than mean or continuous scores, in accordance with Sections 9.10-9.11 of the protocol.

    Measured: 6 months and 12 months

  20. BPI (Brief Pain Inventory) Score Change from Baseline

    Pain will be assessed using BPI, a validated questionnaire that measures both pain intensity and the degree to which pain interferes with daily activities. Each item is scored from 0 to 10, with higher scores indicating worse pain or greater interference.

    Measured: 6 months and 12 months

  21. C-Telopeptide Levels

    Blood levels of C-telopeptide, a marker of bone resorption, will be measured assess changes in bone turnover.

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start9 Sep 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499999
Sponsor's protocol ID
25-550
Acronym
BabyTEARS
Status last verified
Mar 2026
First submitted
24 Mar 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exemestane and Tamoxifen in people with Breast Cancer and Ductal Carcinoma, run by Dana-Farber Cancer Institute at 2 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 17 inclusion and 19 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Judy Garber, MD, MPH (617-632-2282, judy_garber@dfciharvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07499999.

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 30 Mar 2026.

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