Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease

NCT00080756 | Active Not Recruiting Phase 2

• 5 other identifiers: 02164P30CA033572CHNMC-IRB-02164CDR0000355156NCI-2011-00975
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women. PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.

Conditions

brca1 Mutation Carrier; brca2 Mutation Carrier; Breast Cancer

Keywords

breast cancer; BRCA1 mutation carrier; BRCA2 mutation carrier

Outcome Measures

Primary Outcomes (2)

• Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300

  Day 300

• Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years

  2 years

Study Arms (2)

Group 1 (planned risk reduction mastectomy)

EXPERIMENTAL

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.

Biological: therapeutic estradiol; Drug: deslorelin; Drug: therapeutic testosterone; Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Group 2 (continued survaillance)

ACTIVE COMPARATOR

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.

Biological: therapeutic estradiol; Drug: deslorelin; Drug: therapeutic testosterone; Other: active surveillance; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Interventions

therapeutic estradiol BIOLOGICAL

0.35mg/100ul per day as a nasal spray

Group 1 (planned risk reduction mastectomy); Group 2 (continued survaillance)

deslorelin DRUG

1mg/100ul per day as a nasal spray

Group 1 (planned risk reduction mastectomy); Group 2 (continued survaillance)

therapeutic testosterone DRUG

0.275mg/100ul per day as a nasal spray

Group 1 (planned risk reduction mastectomy); Group 2 (continued survaillance)

therapeutic conventional surgery PROCEDURE

Undergo risk reduction mastectomy

Group 1 (planned risk reduction mastectomy)

active surveillance OTHER

Undergo continued surveillance

Group 2 (continued survaillance)

quality-of-life assessment PROCEDURE

Ancillary studies

Group 1 (planned risk reduction mastectomy); Group 2 (continued survaillance)

laboratory biomarker analysis OTHER

Correlative studies

Group 1 (planned risk reduction mastectomy); Group 2 (continued survaillance)

Eligibility Criteria

• Age: 21 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must generally be in good health with lab values and physical examination within normal limits
• Known high risk of breast cancer due to BRCA mutation or empiric risk \> 30% lifetime by the Claus model
• No evidence or history of pervious cancer, except non-melanoma skin cancer
• Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)
• Prior tubal ligation or willing to use a non-hormonal barrier method of contraception
• Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations
• Must be current non-smoker

You may not qualify if:

• GnRHA treatment within 12 months of study entry
• Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
• Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)
• Pregnant or breast-feeding or have been so in the last six months
• Immeasurable breast density on mammogram

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estradiol; deslorelin; Testosterone Propionate; Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone; Androstenols; Androstenes; Androstanes; Testosterone Congeners; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Jeffrey Weitzel, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: March 11, 2004
• Primary Completion: September 15, 2024
• Study Completion: October 15, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (1)