Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms

NCT01194440 | Completed Phase 2 Results

• 2 other identifiers: J1022SKCCC J1022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer. PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast cancer receiving letrozole.

Conditions

Ductal Carcinoma in Situ; Estrogen Receptor-positive Breast Cancer; Progesterone Receptor-positive Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

  12 months

Secondary Outcomes (3)

• AIMSS as Determined by Health Assessment Questionnaire Disability Index (HAQ-DI) Score

  Baseline, 1 month, 3 months, 6 months, 12 months

• AIMSS as Determined by Visual Analog Scale (VAS) Score

  Baseline, 1 month, 3 months, 6 months, 12 months

• Number of Participants Who Discontinue or Change Aromatase Inhibitor (AI) Therapy

  12 months

Study Arms (1)

Arm I - IV Zoledronic Acid Prophylaxis

EXPERIMENTAL

Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.

Drug: letrozole; Drug: zoledronic acid

Interventions

letrozole DRUG

Given orally

Also known as: CGS 20267, Femara, LTZ

Arm I - IV Zoledronic Acid Prophylaxis

zoledronic acid DRUG

Given IV

Also known as: CGP 42446, CGP42446A, NDC-zoledronate, ZOL 446, zoledronate, Zometa

Arm I - IV Zoledronic Acid Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven DCIS or stage I-III invasive carcinoma of the breast that is estrogen and/or progesterone receptor positive by immunohistochemical staining who are considering aromatase inhibitor therapy; women may receive the AI on this study as initial adjuvant hormonal treatment or following tamoxifen; patients must have completed any adjuvant chemotherapy; patients may have received preoperative chemotherapy
• Postmenopausal status, defined as: \>= 60 years of age; or \< 60 years of age and amenorrheic for \>= 12 months prior to day 1 if intact uterus/ovaries; or \< 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or \< 60 years of age, without a uterus, and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or \< 60 years of age and history of bilateral oophorectomy; or prior radiation castration with amenorrhea for at least 6 months; \< 60 years of age and taking medication designed to suppress ovarian function and meets biochemical criteria for menopause (estradiol levels within institutional standards for postmenopausal status; women would have had to be taking the drug for at least 30 days prior to day 1)
• ECOG performance status 0-2
• Patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form

You may not qualify if:

• Concurrent use of hormone replacement therapy
• Concurrent use of tamoxifen; patients taking tamoxifen must discontinue the drug prior to first dose of zoledronic acid
• Concurrent use of other selective estrogen receptor modulator (SERM) such as raloxifene
• Concurrent consumption of soy supplements; routine dietary consumption of soy containing foods will be permitted
• Prior use of an aromatase inhibitor in any setting
• Current bisphosphonate use (oral or intravenous); prior bisphosphonate users would be eligible as long as the use was \> 1 month ago for oral bisphosphonates and/or \> 12 months ago for intravenous bisphosphonates, prior to starting study treatment
• Moderate to severe renal impairment (serum creatinine greater than 2 mg/dL or creatinine clearance less than 50 mL/min)
• Hypersensitivity to letrozole or zoledronic acid or any of its excipients
• Concomitant treatment with oral or intravenous corticosteroids
• Current active dental problems including infection or the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
• Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

Letrozole; Zoledronic Acid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Imidazoles

Results Point of Contact

• Title: Dr. Vered Stearns
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

HopkinsBreastTrials@jhmi.edu

443-287-6489

Study Officials

• Vered Stearns

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 3, 2010
• Study Start: February 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 12, 2018
• Results First Posted: January 9, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)