70 Participants Needed

Hormone Therapy for Early Stage Breast Cancer

EF
EE
YE
Overseen ByYvonne E Taul, RN
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Veronica Morgan Jones
Must be taking: Anti-endocrine
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on investigational agents that could affect the trial, you may need to stop those.

What data supports the effectiveness of the drugs Anastrozole, Letrozole, Exemestane, and Tamoxifen for early-stage breast cancer?

Research shows that Anastrozole, Letrozole, and Exemestane, which are aromatase inhibitors, are more effective than Tamoxifen in improving disease-free survival in postmenopausal women with hormone receptor-positive early-stage breast cancer. Studies like the ATAC trial and others have demonstrated that these drugs are superior to Tamoxifen, making them a preferred choice for adjuvant hormonal therapy.12345

Is hormone therapy for early-stage breast cancer safe for humans?

The ATAC trial, which studied anastrozole and tamoxifen in over 9,000 postmenopausal women with early-stage breast cancer, found that anastrozole has a favorable safety profile compared to tamoxifen. Anastrozole and other aromatase inhibitors like letrozole and exemestane are generally well-tolerated, though long-term safety profiles may differ among them.678910

How does this drug differ from other treatments for early-stage breast cancer?

This drug regimen includes aromatase inhibitors (anastrozole, exemestane, letrozole) and tamoxifen, which are used to block estrogen production or its effects, offering an alternative to traditional hormone therapies. Aromatase inhibitors are particularly effective in postmenopausal women and have been shown to be more effective and better tolerated than some older treatments like megestrol acetate.1011121314

What is the purpose of this trial?

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.

Research Team

II

Irada Ibrahim-zada, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for postmenopausal women with early stage I-II, estrogen-rich breast cancer that's not spread to lymph nodes. They must be able to take anti-endocrine therapy and sign a consent form. Women with progesterone-negative tumors, high-grade tumors, other cancers, or allergies to the study drugs can't join.

Inclusion Criteria

My breast cancer is confirmed and is in the early stages (I or II).
Ability to understand and the willingness to sign a written informed consent document
My doctor says I can receive hormone therapy for my cancer.
See 2 more

Exclusion Criteria

Receiving any other investigational agents that could impact the efficacy of this trial regimen
I am allergic to certain cancer medications like Anastrozole or Tamoxifen.
I do not have any unmanaged ongoing illnesses.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Endocrine Therapy

Participants receive neoadjuvant endocrine therapy with Anastrozole, Letrozole, Exemestane, or Tamoxifen for 6 months

6 months

Surgery

Participants undergo breast conservation surgery to evaluate margin status

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of residual cancer burden and satisfaction with cosmetic outcome

6-12 months

Treatment Details

Interventions

  • Anastrozole 1mg
  • Exemestane 25 mg
  • Letrozole 2.5mg
  • Tamoxifen
Trial Overview The study tests if using neoadjuvant endocrine therapy (Anastrozole, Letrozole, Exemestane or Tamoxifen) before surgery improves outcomes in breast cancer by increasing the chances of completely removing the tumor without leaving any cancerous tissue at the edges.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Endocrine TherapyExperimental Treatment4 Interventions
Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.

Anastrozole 1mg is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Arimidex for:
  • Hormone receptor-positive breast cancer
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Approved in United States as Arimidex for:
  • Hormone receptor-positive breast cancer
  • Prevention of breast cancer in high-risk individuals
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Approved in Canada as Arimidex for:
  • Hormone receptor-positive breast cancer
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Approved in Japan as Arimidex for:
  • Hormone receptor-positive breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Veronica Morgan Jones

Lead Sponsor

Trials
1
Recruited
70+

Irada Ibrahim-zada

Lead Sponsor

Erin Burke

Lead Sponsor

Trials
1
Recruited
70+

Emily Marcinkowski

Lead Sponsor

Trials
1
Recruited
70+

Findings from Research

In postmenopausal women with hormone receptor positive early-stage breast cancer, letrozole is more cost-effective than anastrozole for both treatment-naΓ―ve patients and those already on letrozole, with a cost per quality-adjusted life-year (QALY) gained ranging from $20,276 to $34,356.
Starting treatment with letrozole results in a gain of 0.15 QALYs compared to anastrozole, despite letrozole being $3916 more expensive over a lifetime, indicating its superior efficacy in improving patient outcomes.
Cost effectiveness of letrozole versus anastrozole in postmenopausal women with HR+ early-stage breast cancer.Lipsitz, M., Delea, TE., Guo, A.[2019]
Third-generation aromatase inhibitors (AIs) like anastrozole, letrozole, and exemestane have emerged as effective alternatives to tamoxifen for treating postmenopausal breast cancer, particularly in hormone receptor-positive cases, as shown in the ATAC trial with over five years of follow-up.
Fulvestrant, a new type of estrogen receptor antagonist with no partial agonist activity, represents a promising option in breast cancer treatment, and the review discusses future sequencing strategies for using AIs earlier in treatment regimens.
New developments in the treatment of postmenopausal breast cancer.Howell, A.[2018]
Adjuvant hormonal therapy with tamoxifen significantly reduces the risk of breast cancer recurrence and death in women with early-stage, hormone receptor-positive breast cancer, but it also carries risks of endometrial cancer and thromboembolic events.
Recent trials, including the MA-17 and Intergroup Exemestane Study, show that selective aromatase inhibitors (AIs) like anastrozole and exemestane provide superior disease-free survival compared to tamoxifen, establishing AIs as a preferred treatment option for postmenopausal women.
Adjuvant aromatase inhibitors following tamoxifen for early-stage breast cancer in postmenopausal women: what do we really know?Chung, CT., Carlson, RW.[2019]

References

Cost effectiveness of letrozole versus anastrozole in postmenopausal women with HR+ early-stage breast cancer. [2019]
New developments in the treatment of postmenopausal breast cancer. [2018]
Adjuvant aromatase inhibitors following tamoxifen for early-stage breast cancer in postmenopausal women: what do we really know? [2019]
Letrozole: a review of its use in postmenopausal women with breast cancer. [2018]
The breast cancer continuum in hormone-receptor-positive breast cancer in postmenopausal women: evolving management options focusing on aromatase inhibitors. [2022]
Anastrozole as an adjuvant endocrine treatment for postmenopausal patients with breast cancer: emerging data. [2018]
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]
Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. [2022]
Role of anastrozole in adjuvant therapy for postmenopausal patients. [2019]
New aromatase inhibitors for breast cancer. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Are all aromatase inhibitors the same? A review of controlled clinical trials in breast cancer. [2007]
12.United Statespubmed.ncbi.nlm.nih.gov
Aromatase inhibitors in advanced breast cancer. [2019]
Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
High dehydroepiandrosterone-sulfate predicts breast cancer progression during new aromatase inhibitor therapy and stimulates breast cancer cell growth in tissue culture: a renewed role for adrenalectomy. [2013]
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