Endocrine Therapy for Low-Risk Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Washington University School of Medicine
Must be taking: Endocrine therapy
Must not be taking: Antiretrovirals
Disqualifiers: Prior surgery, Other malignancy, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing if hormone therapy alone can effectively treat breast cancer in women aged 70 or older with certain types of tumors. The therapy works by blocking estrogen, which helps stop cancer cells from growing. Researchers believe this approach could be enough to control the cancer without needing more aggressive treatments.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Anastrozole for low-risk breast cancer?
Research shows that aromatase inhibitors like Anastrozole are more effective and have better tolerability than Tamoxifen for treating hormone-sensitive early breast cancer in postmenopausal women.
12345Is endocrine therapy for low-risk breast cancer safe?
Research shows that newer endocrine therapies like anastrozole, letrozole, and exemestane are generally well-tolerated and have fewer side effects compared to tamoxifen, which has been used for many years. These treatments have been shown to be safe for postmenopausal women with hormone-sensitive breast cancer.
12367How is the drug Anastrozole, Exemestane, Fulvestrant, Goserelin, Tamoxifen unique for low-risk breast cancer?
This drug combination is unique because it uses a mix of aromatase inhibitors (which block estrogen production) and selective estrogen receptor modulators (which block estrogen's effects) to treat low-risk breast cancer, offering an alternative to chemotherapy with potentially fewer side effects.
158910Eligibility Criteria
This trial is for women aged 70 or older with a specific type of breast cancer that's sensitive to hormones and hasn't spread widely (ER+ operable invasive breast cancer, cT1 or T2, N0-1, M0). Participants should have low levels of a protein called Ki67, be able to perform daily activities with some limitations (ECOG ≤ 3), and not have had previous surgery for this cancer. Women with HIV on antiretroviral therapy, other recent cancers, or severe illnesses are excluded.Inclusion Criteria
I am capable of only limited self-care, confined to my bed or chair more than 50% of waking hours.
My cancer is estrogen receptor positive and HER2 negative.
Your Ki67 score, which shows how fast cells are growing, is less than or equal to 30%, or you have a low to intermediate mitotic index.
+4 more
Exclusion Criteria
Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements
You have had allergic reactions to similar medicines or substances like the ones used in the study.
I have had surgery for my cancer.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neoadjuvant Endocrine Therapy
Participants receive neoadjuvant endocrine therapy, including options like goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen, with office visits every 3 to 6 months for tumor assessment.
12 months
Office visits every 3 to 6 months
Follow-up
Participants are monitored for response and progression using RECIST criteria, and quality of life is assessed at baseline, Year 1, and Year 2.
6 months
Participant Groups
The study tests if endocrine therapy alone can control breast cancer in elderly women without the need for surgery. It involves treatments like Fulvestrant, Tamoxifen, Anastrozole, Exemestane and Goserelin. The effectiveness will be measured by changes in tumor size using ultrasound or mammogram and quality of life assessments.
1Treatment groups
Experimental Treatment
Group I: Endocrine therapy aloneExperimental Treatment7 Interventions
* Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen
* Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment
* After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy
* Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire
* Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)
Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Arimidex for:
- Breast cancer
- Early breast cancer in postmenopausal women
🇺🇸 Approved in United States as Arimidex for:
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
🇨🇦 Approved in Canada as Arimidex for:
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
🇯🇵 Approved in Japan as Arimidex for:
- Breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
Genomic Health®, Inc.Industry Sponsor
References
Adjuvant aromatase inhibitor therapy for early breast cancer: A review of the most recent data. [2018]Tamoxifen is the established adjuvant treatment for postmenopausal women with hormone-sensitive early breast cancer. However, the side-effects associated with tamoxifen therapy have prompted a search for safer and potentially more effective endocrine agents. Results from randomized trials of the third-generation aromatase inhibitors, anastrozole, letrozole and exemestane, demonstrating improved efficacy compared with tamoxifen and favorable tolerability profiles, are discussed in this review.
New developments in the treatment of postmenopausal breast cancer. [2018]In recent years, new agents have challenged tamoxifen as the standard endocrine therapy for postmenopausal breast cancer. This article reviews developments with regard to the third-generation aromatase inhibitors (AIs)--anastrozole, letrozole and exemestane--and fulvestrant, the first of a new type of estrogen receptor antagonist that, unlike tamoxifen, has no partial agonist activity. The final results of the "Arimidex", Tamoxifen, Alone or in Combination (ATAC) trial, at a median follow-up of more than five years, and recent results from switching studies with anastrozole and exemestane, strengthen the position of these AIs as adjuvant treatment for hormone receptor-positive early breast cancer. Sequencing options for the future are also discussed because non-steroidal AIs are increasingly used early in the treatment sequence.
Tamoxifen--what next? [2019]Most patients with advanced breast cancer (ABC) ultimately die due to disease progression. Consequently, treatments for ABC are predominantly palliative in nature and, therefore, the tolerability profile of a given treatment is particularly relevant in these patients. While cytotoxic chemotherapy and endocrine therapy exhibit efficacy in hormone-sensitive, advanced disease, it is endocrine therapy that combines efficacy with minimal acute toxicity. Tamoxifen has been the chosen endocrine therapy for postmenopausal, hormone-sensitive, ABC for over 20 years. More recently, new endocrine agents with different mechanisms of action from tamoxifen have been introduced. Evidence indicates that the aromatase inhibitors anastrozole (Arimidex; AstraZeneca; Wilmington, DE), letrozole (Femara; Novartis Pharmaceuticals Corp.; East Hanover, NJ) and exemestane (Aromasin; Pharmacia Corp.; Peapack, NJ) offer superior efficacy and tolerability to tamoxifen in the first-line treatment of postmenopausal, hormone-sensitive ABC. Similarly, after tamoxifen failure, fulvestrant (Faslodex; AstraZeneca), a new estrogen receptor (ER) antagonist that downregulates the ER, is at least as effective as anastrozole, is well tolerated, and is not cross-resistant with tamoxifen. Unlike tamoxifen, fulvestrant has no known agonist effects. The sequential use of such agents may prolong the time during which endocrine therapies can be used, thereby avoiding the more acute toxicities associated with cytotoxic chemotherapy. Indeed, a series of studies has shown that this sequential use is a relevant, active, and well-tolerated option. Establishing the comparative efficacies and optimal sequences that incorporate the newer endocrine agents will be central in determining the future role of hormonal therapy in ABC; the results of this work will determine the relative place of tamoxifen in what is a rapidly changing therapeutic environment.
Aromatase inhibitors in breast cancer: an update. [2018]Tamoxifen has been the endocrine treatment of choice for patients with breast cancer. The development of selective aromatase inhibitors has offered an alternative management approach for patients in whom a hormonal approach is indicated.
Longitudinal trends in utilization of endocrine therapies for breast cancer: an international comparison. [2022]Endocrine therapy is an effective treatment for post-menopausal women with 'oestrogen receptor-positive' invasive breast cancers. There are two main types of endocrine therapies: selective oestrogen receptor modulators (tamoxifen) and aromatase inhibitors (anastrozole, letrozole and exemestane). The aim of this study was to compare the patterns of use of endocrine therapies for breast cancer in women between nine developed countries.
A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. [2018]Results of the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial have shown that tamoxifen is associated with a significantly higher incidence of gynecologic adverse events than anastrozole.
Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. [2022]The Arimidex (anastrozole), Tamoxifen, Alone or in Combination (ATAC) trial was designed to compare the efficacy and safety of anastrozole with tamoxifen as adjuvant treatment for postmenopausal women with early-stage breast cancer. After an extended follow-up beyond the 5 years of treatment, we aimed to assess the safety, tolerability, and risk-benefit indices of these compounds.
Neoadjuvant use of endocrine therapy in breast cancer. [2022]Neoadjuvant endocrine therapy is becoming increasingly popular as a safe and effective alternative to chemotherapy in selected patients. Large randomized studies have been published comparing tamoxifen with steroidal and nonsteroidal aromatase inhibitors, with favorable results for aromatase inhibitors letrozole, anastrozole, and exemestane. Endocrine therapy can be used in the neoadjuvant setting for conversion of inoperable breast tumors to operable, and from potential mastectomy to breast-conserving surgery. The use of endocrine agents in this setting also provides an opportunity for the study of their biological effects upon tumor.
[Adjuvant endocrine therapy in breast cancer. Management of early-risk relapse]. [2013]The goal of adjuvant endocrine therapy for early breast cancer is to prolong overall survival and improve the quality of life of patients. Studies on breast cancer show an early peak of recurrence at two years after surgery and distant recurrences that are responsible for a significant reduction in overall survival. Tamoxifen has been the standard of adjuvant endocrine therapy in breast cancer for years, however only about half of relapses are prevented and there is an early occurrence of serious adverse events due to agonistic estrogenic activity of tamoxifen, such as an increase in the risk of endometrial hyperplasia and venous thromboembolism. The use of aromatase inhibitors is changing this standard with studies covering various clinical settings. They have shown a benefit in many situations, such as an extension of endocrine therapy by tamoxifen, sequential hormonotherapy or up-front adjuvant therapy with aromatase inhibitors.
Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women. [2022]Endocrine therapy removes the influence of oestrogen on breast cancer cells and so hormonal treatments such as tamoxifen, megestrol acetate and medroxyprogesterone acetate have been in use for many years for advanced breast cancer. Aromatase inhibitors (AIs) inhibit oestrogen synthesis in the peripheral tissues and have a similar tumour-regressing effect to other endocrine treatments. Aminoglutethimide was the first AI in clinical use and now the third generation AIs, anastrozole, exemestane and letrozole, are in current use. Randomised trial evidence on response rates and side effects of these drugs is still limited.