Metastatic Breast CancerNASBP-B-09NCT06154590
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
An observational study of Metastatic Breast Cancer and Tumor, run by DR. DIANE CHISESI NFS. MD. PHD. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 44 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Breast Cancer, Tumor, Muscle Neoplasms
- What is being tested?
- Method(s)1 Attribution and Method(s)2 Attribution,
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Sep 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Show all 30Show fewer
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
PNAF Medical
Colorado Springs, Colorado, 80934-2567
USCMDR Diane Chisesi, MD PhD LPC, 719-477-0295, Dchisesi@comcast.net
Dr. Diane Chisesi, NFS MD PhD, (719) 477-0295, Dchisesi@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer, Tumor, Muscle Neoplasms, Chronic Pain
- Being tested
- Method(s)1 Attribution, Method(s)2 Attribution,
- Keywords
- Dose Unit, Participants, Confidence Intervals, Cmax
- Medical subject headings
- Breast Neoplasms, Neoplasms, Muscle Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method(s)1 AttributionDrug
Also called anastrazole
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,Drug
Also called Tamoxifen Citrate, NOLVADEX, L phenylalanine mustard (P), Fluorouracil (f)
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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)). Receives: Drug: Method(s)1 Attribution; Drug: Method(s)2 Attribution, | |
| 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 Receives: Drug: Method(s)1 Attribution; Drug: Method(s)2 Attribution, |
What is being measured
The primary outcome is the main question the study is designed to answer.
The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy
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)
Measured: At a median follow-up of 33 months
female, effective clinical care
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
Measured: 33 months
female, effective clinical care
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.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study startJul 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- DR. DIANE CHISESI NFS. MD. PHD.
- Sponsor type
- University, hospital or other
- Collaborators
- IRB
- Responsible party
- Sponsor-investigator, DR. DIANE CHISESI NFS. MD. PHD., Paradyne Networks A Foundation
- Investigators
- USCMDR Diane Chisesi, MD PhD CI, Principal investigator, Chisesi, Diane M,: Army/Air Force/Mil/DHS/Other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154590
- Sponsor's protocol ID
- 1,20,NAS BP-B-09
- Other IDs
- CO4.588.839.500, 11063, IRB00000553, IORG0000432
- Acronym
- NASBP-B-09
- Status last verified
- Nov 2023
- First submitted
- 20 Mar 2015
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06154590
- Acronym / sponsor ID
- NASBP-B-09 / 1,20,NAS BP-B-09
- Conditions
- Metastatic Breast Cancer, Tumor, Muscle Neoplasms, Chronic Pain
- Keywords
- Dose Unit, Participants, Confidence Intervals, Cmax
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DR. DIANE CHISESI NFS. MD. PHD.University, hospital or other
- Collaborators
- IRB
- Study start
- Jul 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Method(s)1/PIF Used to Evaluate | – | Drug: Method(s)1 Attribution, Drug: Method(s)2 Attribution,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)2/PIF Used to Evaluate | – | Drug: Method(s)1 Attribution, Drug: Method(s)2 Attribution,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 |
Who may qualify
- Ages
- 44 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Method(s)1 AttributionAlso: anastrazoleIntervention(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.) | Drug | Method(s)1/PIF Used to Evaluate, Method(s)2/PIF Used to Evaluate |
| Method(s)2 Attribution,Also: Tamoxifen Citrate, NOLVADEX, L phenylalanine mustard (P), Fluorouracil (f)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.) | Drug | Method(s)1/PIF Used to Evaluate, Method(s)2/PIF Used to Evaluate |
Primary outcome
The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy
Time frame: At 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 care
Time frame: 33 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 care
Time frame: 12-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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Results publicationAnastrozole 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.
- Results publicationDuctal 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)
- Results publicationDuctal 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.
- Anastrozole, Chemical notes and resources, clinicaltrials.govLink provided by the sponsor.
- ChemIDplus Advanced, AnastrozoleLink provided by the sponsor.
- ToxNet data in PubChemLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
USCMDR Diane Chisesi, MD PhD CI principal investigator
Chisesi, Diane M,: Army/Air Force/Mil/DHS/Other
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Tumor, run by DR. DIANE CHISESI NFS. MD. PHD. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact USCMDR Diane Chisesi, MD PhD LPC. ((719) 477-0295, Dchisesi@comcast.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The combination of anastrozole and NOLVADEX (tamoxifen citrate)was added to adjunct cytotoxic chemothrapy (time frame: At a median follow-up of 33 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06154590, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.