Anastrozole Adjuvant Trial - Study of Anastrozole Compared to NOLVADEX (Tamoxifen Citrate) for Adjuvant Treatment of Early Breast Cancer Clinical Studies), Adjunct Cytotoxic Chemotherapy and Malignant Joint Tumor

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
DR. DIANE CHISESI NFS. MD. PHD.
Study ID
NCT06154590
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
44 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • Method(s)1 Attribution — DRUG
    Intervention(s): "Attribution" defines the relationship between the adverse event and the investigational agent(s)/intervention. Assign the appropriate category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite. Definitions: Use the Adverse Event Dose Units- Indicate the dosing units (e.g., mg) administered to the patient. TAC, Reporting Group: Participants with Disease, Description: Presence of Disease as Defined by positive reference test. Dosage Form: 1mg Anastrozole, given once daily. 20 mg NOLVADEX (tamoxifen citrate) tablet given once daily, (the 20 mg NOLVADEX (tamoxifen citrate) tablet is bioequivalent to the 10 mg NOLVADEX. (tamoxifen citrate) tablets.)
  • Method(s)2 Attribution, — DRUG
    Intervention(s): -"Attribution" defines the relationship between the adverse event and the investigational agent(s)/intervention. Assign the appropriate category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite. Definitions: Use Adverse Events. Dose Units- Indicate the dosing units (e.g., mg) administered to the patient TAC. Reporting Group: Participant without Disease, Description: Absence of Disease as defined by negative reference test. Dosage Form: 1mg Anastrozole, given once daily. 20 mg NOLVADEX (tamoxifen citrate) tablet given once daily, (the 20 mg NOLVADEX (tamoxifen citrate) tablet is bioequivalent to the 10 mg NOLVADEX. (tamoxifen citrate) tablets.)

Study Details

At a median follow-up of 33 months, the combination of anastrozole and NOLVADEX (tamoxifen citrate) did not demonstrate any efficacy benefit when compared to NOLVADEX (tamoxifen citrate) therapy given alone in all patients as well as in the hormone receptor positive subpopulation. This treatment arm was discontinued from the trial. This study is now a combination therapy whereas the median duration of adjuvant treatment for safety evaluation is 59.8 months and 59.6 months for patients receiving anastrozole 1 mg and NOLVADEX (tamoxifen citrate) 20 mg, respectively.

Key Dates

Start date
Jul 31, 2024
Status verified
Nov 2023
Primary completion
Aug 31, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Method(s)1/PIF Used to Evaluate
    Competency Areas- Surgical care to patients with complex or recurrent neoplasms, including diagnosis and management of rare or unusual tumors. Determining disease stage/treatment options for individual cancer patients at time of diagnosis and throughout the disease course. Provide surgical care to patients with complex or recurrent neoplasms, including selecting for surgical therapy in combination with other forms of cancer treatment. Performing palliative surgical. Intervention(s): Use "Attribution", assign category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite. Definitions: Use list of Adverse Events. Dose Units -1 mg, anastrozole. 20 mgs NOLVADEX administer to patient. Tamoxifen citrate was added to melphalan (Lphenylalanine mustard (P) and fluorouracil (F)).
  • Arm: Method(s)2/PIF Used to Evaluate
    Competency Areas- Biologic, pharmacologic, and physiologic rationale for each form of therapy, indications, risks, and benefits of regional and systemic therapy in adjuvant and advanced disease settings. Nonsurgical cancer treatment modalities, including radiotherapy, chemotherapy, immunotherapy, and endocrine therapy. Nonsurgical palliative treatments. Rehabilitative services, including reconstructive surgery and physical rehabilitation. Tumor biology, carcinogenesis, epidemiology, tumor markers, and tumor pathology. Intervention(s): "Attribution" defines the relationship between the adverse event and the investigational agent(s)/intervention. Assign category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite. Definitions: Use list of Adverse Events. Dose Units- adjuvant cytotoxic chemotherapy, added to lequo, low-dose cyclophosphamide methotrexate and fluoruracil

Primary Outcome Measure

The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy [ Time Frame: At a median follow-up of 33 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PNAF MedicalColorado SpringsColorado80934-2567
USCMDR Diane Chisesi, MD PhD LPC
[email protected]
719-477-0295
Dr. Diane Chisesi, NFS MD PhD
[email protected]
(719) 477-0295
USCMDR Diane Chisesi, PI MD PhD (PRINCIPAL_INVESTIGATOR)

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