Clinical trial · Observational
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
Anastrozole Adjuvant Trial - Study of Anastrozole Compared to NOLVADEX (Tamoxifen Citrate) for Adjuvant Treatment of Early Breast Cancer (Clinical Studies), Tamoxifen Citrate Was Added to Adjunct Cytotoxic Chemotherapy- Treatment of Malignant Joint Tumor.
NCT06154590CI-TRIAL-00071911NASBP-B-09not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Muscle Neoplasms | Muscle Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Method(s)1 Attribution | Drug | — | UNRESOLVED |
| Method(s)2 Attribution, | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Method(s)1/PIF Used to Evaluate
- description
- 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)).
- interventionNames
- Drug: Method(s)1 Attribution
- Drug: Method(s)2 Attribution,
- label
- Method(s)2/PIF Used to Evaluate
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 44 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * The Median Duration of Adjuvant Treatment for 59.8 Months and 59.6 Months for Patients Receiving Anastrozole 1 mg and NOLVADEX (Tamoxifen Citrate) 20 mg. * 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: * 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 sub-population. This treatment arm was discontinued from the trial.
References
Publications (3)
- RESULTAnastrozole 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.
- RESULTDuctal 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)
- RESULTDuctal 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.