Clinical trial NCT06154590: 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
Official title: 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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Breast Cancer
Tumor
Muscle Neoplasms
Chronic Pain
Keywords: Dose Unit
Participants
Confidence Intervals
Cmax
Lead sponsor: Paradyne Networks A Foundation
Sponsor class: OTHER
Collaborators: name: IRB
First posted: 2023-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 44
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the anastrozole adjuvant trial, co-administration of anastrozole 1mg, and (tamoxifen citrate) tablets given twice a day vs. a 20 mg NOLVADEX , In cytosols derived from human breast adenocarcinomas, tamoxifen competes with estradiol for estrogen receptor protein, absorption and distribution. After initiation of therapy, steady state concentrations for tamoxifen are achieved in about 4 weeks and steady-state concentrations for N-desmethyl tamoxifen are achieved in about 8 weeks, suggesting a half-life of approximately 14 days for this metabolite.

For this Study population-Suggest: The median duration of adjuvant treatment for safety evaluation is 59.8 months and 59.6 months for patients receiving start dose anastrozole 1 mg and NOLVADEX (tamoxifen citrate) 20 mg, respectively.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy
timeFrame: At a median follow-up of 33 months
measure: female, effective clinical care
timeFrame: 33 months
measure: female, effective clinical care
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
measure: male. effective clinical care
timeFrame: 6 months
Locations:
city: Colorado Springs
country: United States
facility: PNAF Medical
state: Colorado
Study officials:
affiliation: Chisesi, Diane M,: Army/Air Force/Mil/DHS/Other
name: USCMDR Diane Chisesi, MD PhD CI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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)
citation: 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.