Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer.

Breast Cancer Clinical Trial

— BabyTears  

Official title:

Randomized Double Blind Phase 2 Trial of Baby Tamoxifen Versus Baby Exemestane in Post-menopausal Women at High Risk for Breast Cancer. BabyTEARS (Baby Tamoxifen or Exemestane Assessment Randomized Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364267
• Other study ID #: BabyTears
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: April 2024
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Andrea U De Censi, MD
• Phone: +39.010.563.4501
• Email: andrea.decensi[@]galliera.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life.

Description:

It is a multicenter, randomized, double blind, superiority phase IIb trial. Eligible patients will be randomized with a 1:1 ratio into: ARM 1: BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months or unless progression, SAE, medical decision, patient withdrawal occur. ARM 2: BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 months or unless progression, SAE, medical decision, patient withdrawal occur. Blinding will be guaranteed by over-encapsulation of active tablet agents with an AA capsule in a 6-month bottle. In both arms, treatment should begin within 30 days from randomization. Tamoxifen and Exemestane will be provided for free by the Study Sponsor. After study completion, participants will be unblinded and treated according to local study guidelines. Clinical visit will be performed every 6 months (±14 days) with physical examination vital signs and weight and girth measurement, ECOG PS, MENQOL questionnaire (0, 6, 12 months), review of self-reported compliance, concomitant medications, AEs assessment, and physical exam. Telephone/video contact may be allowed at 3 and 9 months, whereas baseline, 6 months and 12 months visits are necessary for blood and stool collection and biomarker assessment. Blood serum and stool samples for centralized storage at IEO, Milan, Italy, will be collected at different time points.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Postmenopausal women, defined as amenorrhea for 6-12 months and FSH> 45 mU/mL, or

amenorrhea for at least 12 months, and any of the following criteria:

• Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (>5%) DCIS or 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, the BCRAT model (https://tools.bcsc-scc.ucdavis.edu/BC5yearRisk/#/), or the CANRISK model (https://www.canrisk.org/), or Tyrer-CuzickmodelV8

(https://ibis-risk-calculator.magview.com/), 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.

2. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1.

3. Able to swallow oral medications.

4. 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.

5. Ability to understand and the willingness to sign a written informed consent document.

6. Women of all races and ethnic groups are eligible for this trial.

7. Mammography performed up to 6 months before the trial consent form signature.

8. DEXA performed up to 12 months before the trial consent form signature.

9. Adequate bone marrow, hepatic and renal functions within 12 months from the date of

trial consent form signature as defined below:

1. Absolute neutrophil count (ANC) = 1500/mm3

2. Platelets = 100,000/ mm3

3. Hemoglobin = 10.0 g/ dL

4. Total bilirubin = 1.5 x Upper Limit of Normal (ULN)

5. ALT and AST = 3.0 x ULN

6. Serum creatinine = 1.5 x ULN or eGFR = 60 mL/ min/ 1.73 m2.

Exclusion Criteria:

• 1. Pre/perimenopausal women (amenorrhea < 6 months and FSH<45 mU/mL) are not eligible because of risk of uncontrolled ovarian stimulation with exemestane.

2. History of DVT or PE. 3. Endometrial cancer. 4. Macular disorders. 5. Inability to comply with study procedures. 6. Prior use of antiestrogens within 12 months from the date of the trial consent form signature.

7. Use of hormone replacement therapy (HRT) within 3 months from the date of the trial consent form signature.

8. Severe osteoporosis (T score <-2.5 at either spine or hip), or recent vertebral fracture (within 6 months) not treated with zolendronic acid or denosumab.

9. Participants receiving any medications or substances that are inhibitors or inducers of CYP450 2D6 should be carefully assessed. Selective serotonin reuptake inhibitors (SSRIs) are allowed although should be carefully registered and discouraged in de novo users, particularly fluoxetine, paroxetine, bupropion.

10. Certain anti-antimicrobials such as terbinafine and quinidine; and other medications like cinacalcet may reduce the effectiveness of tamoxifen.

11. Concomitant use of CYP3A4 inducer medication (rifampicin, phenytonin, carbamazepine, phenobarbital, and St. John's wort) is contraindicated.

12. Current use of warfarin. Antiaggregants and new oral anticoagulants are allowed.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tamoxifen 10 MG
Blinded tamoxifen 10 mg every other day
• Exemestane 25 MG
Blinded exemestane 25 mg every other day

Locations

Country	Name	City	State
Italy	E.O. Ospedali Galliera	Genova

Sponsors (5)

Lead Sponsor	Collaborator
Andrea DeCensi	Breast Cancer Research Foundation, Dana-Farber/Brigham and Women's Cancer Center, Herbert Irving Comprehensive Cancer Center, Istituto Europeo di Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life MEnQol	The primary endpoint is the change after 12 months of treatment between arms in the physical domain, including musculoskeletal/joint pain, of the Menopause-Specific Quality of Life Questionnaire (MENQOL), a validated tool to measure symptoms related to menopause or estrogen depletion potentially worsened by babyexe or babytam. Questionnaire scale setup: no, if yes the scale is from 0 (Not at all bothered) to 6 (extremely bothered).	12 months
Secondary	Other domains	Assessment of other domains of MENQOL such as vasomotor symptoms, sexual and psychological disturbances. Questionnaire scale setup: no, if yes the scale is from 0 (Not at all bothered) to 6 (extremely bothered).	12 months
Secondary	PMAS questionnaire	Pill adherence through PMAS - which is the Promise Medication Adherence Scale. Questionnaire setup: scale from 1 (Strongly disagree - Never - Not at all) to 5 (Strongly agree - Always - very much)	12 months
Secondary	Customer Satisfaction questionnaire	Factors related to study participation or refusal before study entry, including breast cancer-related worry and presence of life style risk factors, and participant satisfaction of study explanation. Questionnaire setup: questions about accepting/refusing the trial, and satisfaction scale from 1 (Strongly agree) to 5 (strongly disagree).	12 months
Secondary	BPI	The BPI Brief Pain Inventory short form questionnaire. Querstionnaire setup: pain is evaluated from 0 (best result) to 10 (worst result).	12 months
Secondary	Sex hormones biomarkers	estradiol, estrone, testosterone, androstenedione, sex hormone binding globulin	12 months
Secondary	Insulin biomarker	Insulin growth factor I	12 months
Secondary	Bone biomarker	C-terminal telopeptide	12 months