CLINICAL TRIALS PROFILE FOR ANASTROZOLE

505(b)(2) Clinical Trials for anastrozole

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01300351 ↗	Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women	Completed	AstraZeneca	Phase 3	2011-03-01	The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.

All Clinical Trials for anastrozole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002644 ↗	Tamoxifen for the Prevention of Breast Cancer in High-Risk Women	Active, not recruiting	Institute of Cancer Research, United Kingdom	Phase 3	1994-01-01	The International Breast Cancer Intervention Study I (IBIS-I) was designed to investigate the use of tamoxifen in preventing breast cancer in women with a higher risk of developing the disease. Recruitment of women to IBIS-I ended in March 2001 and it recruited 7154 women from 36 centres in 9 countries. The results of the study showed that tamoxifen reduced the incidence of breast cancer by one third in these high risk women but with some serious side effects. IBIS-II was designed to continue the work started in IBIS-I by examining the role of anastrozole in the prevention of breast cancer which we hope will reduce breast cancer by even more than tamoxifen with less serious side effects.
NCT00002644 ↗	Tamoxifen for the Prevention of Breast Cancer in High-Risk Women	Active, not recruiting	Queen Mary University of London	Phase 3	1994-01-01	The International Breast Cancer Intervention Study I (IBIS-I) was designed to investigate the use of tamoxifen in preventing breast cancer in women with a higher risk of developing the disease. Recruitment of women to IBIS-I ended in March 2001 and it recruited 7154 women from 36 centres in 9 countries. The results of the study showed that tamoxifen reduced the incidence of breast cancer by one third in these high risk women but with some serious side effects. IBIS-II was designed to continue the work started in IBIS-I by examining the role of anastrozole in the prevention of breast cancer which we hope will reduce breast cancer by even more than tamoxifen with less serious side effects.
NCT00003199 ↗	Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-11-01	This phase II trial studies how well giving combination chemotherapy and peripheral blood stem cell transplant followed by aldesleukin and sargramostim works in treating patients with inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy, such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together with sargramostim may kill more tumor cells
NCT00003199 ↗	Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer	Completed	Fred Hutchinson Cancer Research Center	Phase 2	1997-11-01	This phase II trial studies how well giving combination chemotherapy and peripheral blood stem cell transplant followed by aldesleukin and sargramostim works in treating patients with inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy, such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together with sargramostim may kill more tumor cells
NCT00003782 ↗	Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes	Completed	National Cancer Institute (NCI)	Phase 3	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer with positive axillary lymph nodes.

Clinical Trial Conditions for anastrozole

Condition Name

Condition Name for anastrozole
Intervention	Trials
Breast Cancer	146
Metastatic Breast Cancer	20
Breast Neoplasms	17
Advanced Breast Cancer	12

Condition MeSH

Condition MeSH for anastrozole
Intervention	Trials
Breast Neoplasms	245
Carcinoma	16
Neoplasms	9
Carcinoma in Situ	7

Clinical Trial Locations for anastrozole

Trials by Country

Trials by Country for anastrozole
Location	Trials
Canada	134
Italy	113
Spain	109
China	90
Japan	84

Trials by US State

Trials by US State for anastrozole
Location	Trials
California	56
Florida	47
New York	46
Massachusetts	45
Texas	45

Clinical Trial Progress for anastrozole

Clinical Trial Phase

Clinical Trial Phase for anastrozole
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	84
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for anastrozole
Clinical Trial Phase	Trials
Completed	143
Recruiting	43
Active, not recruiting	38

Clinical Trial Sponsors for anastrozole

Sponsor Name

Sponsor Name for anastrozole
Sponsor	Trials
AstraZeneca	67
National Cancer Institute (NCI)	42
Novartis Pharmaceuticals	15

Sponsor Type

Sponsor Type for anastrozole
Sponsor	Trials
Other	327
Industry	198
NIH	51

Anastrozole Market Analysis and Financial Projection

Anastrozole: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Anastrozole

Anastrozole is an oral non-selective aromatase inhibitor primarily used for the adjuvant treatment of early-stage, hormone receptor-positive breast cancer in postmenopausal women. It works by inhibiting the aromatase enzyme, thereby reducing estrogen production in the body and slowing the growth of estrogen-dependent tumors[3][5].

Clinical Trials and Efficacy

The IBIS-II Trial

One of the most significant clinical trials involving anastrozole is the IBIS-II (International Breast Cancer Intervention Study II) trial. This randomized, double-blind trial involved approximately 4,000 postmenopausal women who were at high risk of developing breast cancer due to factors such as a strong family history, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or certain types of high-risk benign breast disease.

• Short-Term Outcomes: The trial found that taking anastrozole for 5 years significantly reduced the incidence of breast cancer. Only 35 women in the anastrozole group developed breast cancer compared to 89 women in the placebo group during the first 5 years[1][4].

• Long-Term Outcomes: The trial also demonstrated a long-term benefit of anastrozole. After 12 years of follow-up, 85 women in the anastrozole group had developed breast cancer, compared to 165 women in the placebo group. This indicates a reduction in breast cancer risk of approximately 49% compared to the placebo group[1][4].

Side Effects and Safety

The trial highlighted that while the side effects were similar in both groups, women taking anastrozole experienced more joint pain or stiffness, hot flushes, and dry eyes. However, no new or problematic long-term side effects were reported over the 12-year follow-up period[1].

Market Analysis

Current Market Status

The global anastrozole tablets market has been growing steadily due to several key factors:

• Increasing Incidence of Hormone Receptor-Positive Breast Cancer: Approximately 70% of breast cancer cases are hormone receptor-positive, making anastrozole a crucial treatment option[3].

• Advancements in Treatment Strategies: New formulations and combination therapies, as well as advancements in personalized medicine, are enhancing the efficacy of anastrozole and expanding its market share[3].

• Regulatory Approvals: Recent regulatory approvals for new indications and extended use of anastrozole have broadened its therapeutic applications, contributing to market growth[3].

Market Value and Forecast

As of 2023, the global anastrozole tablets market was valued at approximately $X billion and is expected to grow at a compound annual growth rate (CAGR) over the next five years. This growth is driven by the rising incidence of hormone receptor-positive breast cancer and advancements in cancer treatment protocols[3].

Key Drivers

• New Formulations and Combination Therapies: The introduction of new formulations and combination therapies is showing promising results in clinical trials, enhancing the market's growth potential[3].

• Personalized Medicine: Tailoring treatment plans based on genetic and molecular profiling is optimizing anastrozole therapy, improving patient outcomes and expanding its market share[3].

• Strategic Partnerships: Collaborations between pharmaceutical companies, research institutions, and healthcare providers are driving innovation and market expansion[3].

Restraints

Despite the growth, the market faces some restraints, such as frequent product recalls due to Good Manufacturing Practice (GMP) deviations and potential cross-contamination issues. For example, recalls by Cadila Healthcare and Zydus in 2019 were initiated due to GMP cleaning procedure failures[5].

Investment Opportunities

The anastrozole tablets market presents several investment opportunities:

• Growth Prospects: The increasing prevalence of hormone receptor-positive breast cancer and advancements in treatment strategies create a favorable environment for investment[3].

• Business Expansion: Pharmaceutical companies can explore opportunities in emerging markets where access to advanced cancer treatments is expanding. Expanding product lines and forming strategic partnerships can enhance market presence and drive growth[3].

• Strategic Partnerships: Collaborations with research institutions and healthcare providers are essential for advancing anastrozole’s applications and driving innovation[3].

Recent Market Activities

• Product Launches: Recent launches, such as Aurobindo Pharma Limited's U.S. FDA approval for Anastrozole Tablets USP, 1 mg in July 2020, and Cooper Pharma's launch of ANAZBOL (anastrozole tablets) in India in September 2019, have boosted market revenue[5].

• Regulatory Milestones: Regulatory approvals for expanded indications and new formulations have increased anastrozole’s therapeutic applications, contributing to market growth[3].

Conclusion

Anastrozole has proven to be a highly effective drug in reducing the risk of breast cancer in postmenopausal women, particularly those at high risk. The clinical trials, such as the IBIS-II trial, have demonstrated its efficacy and long-term benefits. The market for anastrozole tablets is growing due to the increasing incidence of hormone receptor-positive breast cancer, advancements in treatment strategies, and regulatory approvals. This presents significant investment opportunities in the pharmaceutical industry.

Key Takeaways

• Efficacy in Breast Cancer Prevention: Anastrozole significantly reduces the risk of breast cancer in high-risk postmenopausal women.
• Long-Term Benefits: The drug continues to reduce breast cancer risk even after treatment is stopped.
• Market Growth: The global anastrozole tablets market is growing due to increasing incidence of hormone receptor-positive breast cancer and advancements in treatment strategies.
• Investment Opportunities: Opportunities exist in emerging markets, new formulations, and strategic partnerships.
• Regulatory Approvals: Recent approvals have expanded anastrozole’s therapeutic applications.

FAQs

1. What is anastrozole used for? Anastrozole is used to treat hormone receptor-positive breast cancer in postmenopausal women by lowering estrogen levels and slowing the growth of estrogen-dependent tumors[3].

2. How does anastrozole work? Anastrozole inhibits the aromatase enzyme, reducing estrogen production in the body and preventing the growth and spread of estrogen-sensitive breast cancer cells[3].

3. What are the common side effects of anastrozole? Common side effects include joint pain or stiffness, hot flushes, and dry eyes[1].

4. What are the recent trends in the anastrozole tablets market? Recent trends include the development of new formulations and combination therapies, advancements in personalized medicine, and regulatory approvals for expanded indications[3].

5. Why is the anastrozole tablets market growing? The market is growing due to the rising incidence of hormone receptor-positive breast cancer, advancements in treatment strategies, and the increasing availability of new formulations and therapies[3].

Sources

1. Cancer Research UK: "A trial looking at anastrozole to prevent breast cancer in postmenopausal women"[1].
2. Market Research Reports Inc.: "Anastrozole - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030"[2].
3. Market Research Intellect: "Anastrozole Tablets Market Surges as New Cancer Treatment Strategies Take Center Stage"[3].
4. The Lancet: "Use of anastrozole for breast cancer prevention (IBIS-II)"[4].
5. Transparency Market Research: "Anastrozole Tablets Market: Rise in Cases of Various Diseases to Drive the Market"[5].