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
NCT ID: NCT06154590
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-07-31
2026-09-30
Brief Summary
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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.
Detailed Description
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Among 29,441 patients with ER positive or unknown breast cancer, 58% were entered into trials comparing NOLVADEX (tamoxifen citrate) to no adjuvant therapy and 42% were entered into trials comparing NOLVADEX (tamoxifen citrate) in combination with chemotherapy vs. the same chemotherapy alone. Among these patients, 54% had node positive disease and 46% had node negative disease.
The Early Breast Cancer Trialists' Collaborative Group (EBCTCG) conducted worldwide overviews of systemic adjuvant therapy for early breast cancer in 1985, 1990, and again in 1995. In 1998, 10-year outcome data were reported for 36,689 women in 55 randomized trials of adjuvant NOLVADEX (tamoxifen citrate) using doses of 20-40 mg/day for 1-5+ years. Twenty-five percent of patients received 1 year or less of trial treatment, 52% received 2 years, and 23% received about 5 years.
Forty-eight percent of tumors were estrogen receptor (ER) positive ( \> 10 fmol/mg), 21% were ER poor ( \< 10 fmol/l), and 31% were ER unknown.
This following study is for an alternate treatment plan. Dose specific.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)).
Method(s)1 Attribution
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,
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.)
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
Method(s)1 Attribution
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,
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.)
Interventions
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Method(s)1 Attribution
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,
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.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Construct Patient Historical Background
* Palliative
* Pediatric- Under 2 Years of Age, 2-18 Years of Age (does unit adjustments )FYI
* Interventional Procedures
* BMD Bone Mineral Density (Data if Obtainable)
* Notate Receptor Levels (Only Women With Both Estrogen and Progesterone
* Levels 10 mo Fmol or Greater)
* Notate Radiation Therapy 6 Months (Male, Prostate Cancer, or SAST, Salvage Androgen Suppression)
* Notate Did Not Utilize Androgen Suppression as Adjunct Therapy to Radiation Therapy, Yes or no.
* Androgen Independent Prostate Cancer
* In addition: (for chronic, non-cancer pain), prescribers should determine whether the patient improves functionally on opioids, which could include an opioid trial, and whether the pain relief improves his/her ability to comply with the overall pain management program.
* Chronic Pain (Benign) Inpatient/Outpatient
* Cancer Pain
* Acute Pain, Inpatient/Outpatient
* Add here: if prudent-2.2.3.8.1.1. Dose Modification (Change)
* Has this patient received either a dose escalation or a de-escalation of this investigational agent during this course of therapy? Use the following codes:
* 1 = Yes, planned (i.e., the dose was changed according to protocol guidelines)
* 2 = Yes, unplanned (i.e., the dose change was not a part of protocol guide-lines)
* 3 = No
* 9 = Unknown
* Note: If the patient has received a previous escalation or de-escalation of this investigational agent and there has been no further change to the dose during this course, answer no.
* Construct a Least Squares Linear Regression Standard Curve, Construct a Least Squares Linear Regression, Peak Height ,
* Using data from the control (0 ppb) and fortified tissue samples, construct a least squares linear regression standard curve by plotting fortified tissue concentration against peak height (average from duplicate dose can include injection if drug is developed into injector, currently use of tablets) for the resulting equation, y = mx -t- b.
* x = concentration (ppb) of results from chemicals or tissue from prior surgeries (if any or in progress for sample tissue)
* y = tamoxifen citrate was added to melphalan \[L-phenylalanine mustard (P) and fluorouracil (f) peak height (average value from duplicate does). This will assist in further studies for set up for adjutant cytotoxic chemotherapy if applicable.
* m = slope
* b = y-intercept
* Healthy volunteers/yes
* Will accept women 59-70 for use of combination drug-(both estrogen and progesterone receptor levels).
Exclusion Criteria
44 Years
59 Years
ALL
Yes
Sponsors
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IRB
UNKNOWN
DR. DIANE CHISESI NFS. MD. PHD.
OTHER
Responsible Party
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DR. DIANE CHISESI NFS. MD. PHD.
USCMDR Diane Chisesi P.I. Eng. NFS. MD. PhD.
Principal Investigators
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USCMDR Diane Chisesi, MD PhD CI
Role: PRINCIPAL_INVESTIGATOR
Chisesi, Diane M,: Army/Air Force/Mil/DHS/Other
Locations
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PNAF Medical
Colorado Springs, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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USCMDR Diane Chisesi, MD PhD LPC
Role: primary
Dr. Diane Chisesi, NFS MD PhD
Role: backup
References
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Anastrozole Adjuvant Trial - Study of Anastrozole compared to NOLVADEX (tamoxifen citrate) for Adjuvant Treatment of Early Breast Cancer (see CLINICAL PHARMACOLOGY - Clinical Studies) and Malignant Joint Tumor.
Ductal Carcinoma in Situ (DCIS) The type and frequency of adverse events in the NSABP B-24 trial was consistent with those observed in the other adjuvant trials conducted with NOLVADEX (tamoxifen citrate)
Ductal Carcinoma in Situ NSABP B-24, a double-blind, randomized trial included women with ductal carcinoma in situ (DCIS). This trial compared the addition of NOLVADEX (tamoxifen citrate) or placebo to treatment with lumpectomy and radiation therapy for women with DCIS. The primary objective was to determine whether 5 years of NOLVADEX (tamoxifen citrate) therapy (20 mg/day) would reduce the incidence of invasive breast cancer in the ipsilateral (the same) or contralateral (the opposite) breast.
Related Links
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Anastrozole, Chemical notes and resources, clinicaltrials.gov
ChemIDplus Advanced, Anastrozole
ToxNet data in PubChem
Other Identifiers
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CO4.588.839.500
Identifier Type: OTHER
Identifier Source: secondary_id
11063
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB00000553
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IORG0000432
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1,20,NAS BP-B-09
Identifier Type: -
Identifier Source: org_study_id