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Anastrozole and Tamoxifen for Early Breast Cancer

This observational study is looking at how two medications, anastrozole and NOLVADEX (tamoxifen citrate), are used in combination for treating early breast cancer. Researchers are comparing the use of both drugs together to tamoxifen alone. The study is interested in how well these treatments work and any side effects they might have. You might be able to join if you are a female between 44 and 59 years old with metastatic breast cancer (cancer that has spread), a tumor, muscle neoplasms (growths), or chronic pain. The study is looking for about 100 participants. The main goal is to see the effectiveness of the combination treatment at 12 and 33 months.

Study design
This is an observational study with a planned enrollment of 100 participants. It is comparing anastrozole plus NOLVADEX (tamoxifen citrate) to NOLVADEX (tamoxifen citrate) alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 12 months and 33 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting
Not specifiedAges 44–59Observational
DR. DIANE CHISESI NFS. MD. PHD.
~100 participants
Updated 2023-12-04 on ClinicalTrials.gov
What's tested:Method(s)1 AttributionMethod(s)2 Attribution,

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy
Measured over At a median follow-up of 33 months
+2 more outcomes measured

Conditions

Metastatic Breast Cancer
Tumor
Muscle Neoplasms
Chronic Pain

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Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • USCMDR Diane Chisesi, MD PhD CI · PRINCIPAL_INVESTIGATOR · Chisesi, Diane M,: Army/Air Force/Mil/DHS/Other

Who to contact

USCMDR Diane Chisesi, MD PhD LPC.
[email protected]
(719) 477-0295
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapyAt a median follow-up of 33 months

    Among women with ER positive or unknown breast cancer and positive nodes who received about 5 years of treatment, overall survival at 10 years was 61.4% for NOLVADEX (tamoxifen citrate) vs. 50.5% for control (logrank 2p \< 0.00001). The recurrence-free rate at 10 years was 59.7% for NOLVADEX (tamoxifen citrate) vs. 44.5% for control (logrank 2p \< 0.00001). Among women with ER positive or unknown breast cancer and negative nodes who received about 5 years of treatment, overall survival at 10 years was 78.9% for NOLVADEX (tamoxifen citrate) vs. 73.3% for control (logrank 2p \< 0.00001). The recurrence-free rate at 10 years was 79.2% for NOLVADEX (tamoxifen citrate) versus 64.3% for control (logrank 2p \< 0.00001)

  • female, effective clinical care33 months

    Breast Cancer Resection Pathology Reporting: pT Category (Primary Tumor) and pN Category (Regional Lymph Nodes) with Histologic Grade: Percentage of breast cancer resection pathology reports that include the pT category (primary tumor), the pN category (regional lymph nodes), and the histologic grade

  • female, effective clinical care12-month

    Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer: Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period \*Although there a newer version of this measure is available (CMS140v2), a substantive error was discovered in the June 2013 version of this electronically specified clinical quality measure. The PQRS will require the use of the prior, December 2012 version of this measure, which is CMS140v1.