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 (NASBP-B-09)

DR. DIANE CHISESI NFS. MD. PHD.

Status: Not yet enrolling

Conditions: Chronic Pain; Tumor; Metastatic Breast Cancer; Muscle Neoplasms

Treatments: Drug: Method(s)1 Attribution; Drug: Method(s)2 Attribution,

Study type: Observational

Funder types: Other

Identifiers

NCT06154590

CO4.588.839.500 (Other Identifier)

11063 (Registry Identifier)

1,20,NAS BP-B-09

IRB00000553 (Other Grant/Funding Number)

IORG0000432 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Of importance: (Special group- node positive disease and node negative disease).

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 44 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

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)).

Treatment:

Drug: Method(s)2 Attribution,

Drug: Method(s)1 Attribution

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

Treatment:

Drug: Method(s)2 Attribution,

Drug: Method(s)1 Attribution