CLINICAL TRIALS PROFILE FOR SOLTAMOX

All Clinical Trials for SOLTAMOX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Canadian Cancer Trials Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Cancer and Leukemia Group B	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Southwest Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

Clinical Trial Conditions for SOLTAMOX

Condition Name

Condition Name for SOLTAMOX
Intervention	Trials
Breast Cancer	8
HER2/Neu Negative	5
Estrogen Receptor Positive	5
Stage IA Breast Cancer	4

Condition MeSH

Condition MeSH for SOLTAMOX
Intervention	Trials
Breast Neoplasms	19
Carcinoma	6
Adenocarcinoma	3
Carcinoma in Situ	3

Clinical Trial Locations for SOLTAMOX

Trials by Country

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Trials by Country for SOLTAMOX
Location	Trials
United States	372
Canada	23
Ireland	14
United Kingdom	5
Australia	5

Trials by US State

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−

Trials by US State for SOLTAMOX
Location	Trials
California	10
North Carolina	10
Wisconsin	9
Illinois	9
Georgia	9

Clinical Trial Progress for SOLTAMOX

Clinical Trial Phase

Clinical Trial Phase for SOLTAMOX
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for SOLTAMOX
Clinical Trial Phase	Trials
Active, not recruiting	7
Recruiting	6
Completed	5

Clinical Trial Sponsors for SOLTAMOX

Sponsor Name

Sponsor Name for SOLTAMOX
Sponsor	Trials
National Cancer Institute (NCI)	14
Cancer and Leukemia Group B	3
Southwest Oncology Group	3

Sponsor Type

Sponsor Type for SOLTAMOX
Sponsor	Trials
Other	33
NIH	14
Industry	5

SOLTAMOX: Clinical Trials Update, Market Analysis, and Projections

Introduction to SOLTAMOX

SOLTAMOX, an oral liquid formulation of tamoxifen citrate, is a crucial medication in the treatment of breast cancer, particularly for patients who have difficulty swallowing tablets. Here, we will delve into the clinical trials, market analysis, and future projections for SOLTAMOX.

Clinical Overview and Trials

Mechanism of Action

SOLTAMOX works as a selective estrogen receptor modulator (SERM), competitively binding to estrogen receptors on tumors and other tissue targets, thereby reducing DNA synthesis and inhibiting estrogen effects. This mechanism is effective in treating estrogen receptor-positive breast cancer, especially in pre-menopausal women[2][5].

Key Clinical Trials

• NSABP P-1 and B-14 Trials: These trials have been pivotal in establishing the efficacy of tamoxifen. The NSABP P-1 trial showed a significant reduction in the cumulative rates of invasive and non-invasive breast cancer. The NSABP B-14 trial demonstrated that 5 years of tamoxifen treatment was optimal, with no additional benefit from extending treatment beyond this period[5].

Market Analysis

Current Market Size and Share

As of the latest data, SOLTAMOX holds a small but significant share of the U.S. tamoxifen market. With an estimated 2% market share, peak sales of SOLTAMOX are projected to be around $25 million, although this figure is modest compared to the broader tamoxifen market[2].

Market Drivers

The growth of the solid tumor therapeutics market, which includes breast cancer treatments, is driven by several factors:

• Increasing Incidence of Cancer: The rising number of cancer cases globally, including breast cancer, drives the demand for effective treatments like SOLTAMOX[3].
• Research and Development: Continuous R&D activities in solid tumor therapeutics, including new formulations and combination therapies, are expected to boost market growth[3].
• Government Initiatives: Increased government initiatives for cancer awareness and funding for cancer research also contribute to market expansion[3].

Market Projections

Solid Tumor Therapeutics Market

The solid tumor therapeutics market, within which SOLTAMOX operates, is expected to grow significantly. By 2029, this market is projected to reach USD 283.83 billion, growing at a CAGR of 8.20% from 2024 to 2029. North America is expected to hold the largest market share due to high cancer incidence and significant R&D investments[3].

SOLTAMOX Specific Projections

Given its niche position, SOLTAMOX is expected to maintain a steady market presence. The sales forecast indicates that while the initial launch year may see modest sales around $3 million, this figure is expected to grow to near $20 to $25 million by the time of patent expiration. The long-term use of SOLTAMOX, often up to five years, ensures a consistent revenue stream for the company[2].

Competitive Landscape

Key Players

While SOLTAMOX is a product of DARA Biosciences, the broader solid tumor therapeutics market includes major players such as Amgen Inc., AstraZeneca PLC, Hoffmann-La Roche AG, Eli Lilly and Company, and GSK plc. These companies are actively involved in developing and marketing various cancer treatments, including those for breast cancer[3].

Clinical Trials and Development Trends

Current Clinical Trials

The landscape of clinical trials is evolving, with a focus on advanced and combination therapies. For instance, trials like the ones involving STX-478 and elacestrant are exploring new avenues in treating solid tumors, including breast cancer. These trials often involve multiple phases and combinations with other antineoplastic agents, reflecting the complex and multifaceted approach to cancer treatment[1].

Impact on SOLTAMOX

While SOLTAMOX is an established treatment, the ongoing development of new therapies may influence its market position. However, its unique formulation and established efficacy ensure it remains a viable option for patients who require an oral liquid formulation of tamoxifen.

Conclusion

SOLTAMOX, as an oral liquid formulation of tamoxifen citrate, plays a significant role in the treatment of breast cancer. With a projected market growth driven by increasing cancer incidence and R&D activities, SOLTAMOX is expected to maintain its market presence. Here are the key takeaways:

Key Takeaways

• Established Efficacy: SOLTAMOX has been proven effective in reducing breast cancer incidence through clinical trials like NSABP P-1 and B-14.
• Market Growth: The solid tumor therapeutics market, including SOLTAMOX, is expected to grow at a CAGR of 8.20% from 2024 to 2029.
• Sales Projections: SOLTAMOX sales are projected to grow from $3 million in the initial launch year to near $20 to $25 million by the time of patent expiration.
• Competitive Landscape: The market includes major players, but SOLTAMOX's unique formulation ensures its continued relevance.

FAQs

What is SOLTAMOX used for?

SOLTAMOX is used to treat breast cancer, particularly estrogen receptor-positive breast cancer, by acting as a selective estrogen receptor modulator (SERM)[2].

What is the current market size of SOLTAMOX?

SOLTAMOX holds an estimated 2% share of the U.S. tamoxifen market, with peak sales projected at around $25 million[2].

How does SOLTAMOX compare to other tamoxifen formulations?

SOLTAMOX is the only FDA-approved oral liquid formulation of tamoxifen available in the U.S., making it a unique option for patients who have difficulty swallowing tablets[2].

What are the key drivers of the solid tumor therapeutics market?

The key drivers include the increasing incidence of cancer, surging R&D activities, and rising government initiatives for cancer awareness[3].

What is the projected growth rate of the solid tumor therapeutics market?

The solid tumor therapeutics market is expected to grow at a CAGR of 8.20% from 2024 to 2029[3].

Which region holds the largest market share in the solid tumor therapeutics market?

North America holds the largest market share due to high cancer incidence and significant R&D investments[3].

Sources

1. UCSF Breast Cancer Clinical Trials - UCSF Health
2. Small-Cap Research: DARA Biosciences - Q4cdn
3. Solid Tumor Therapeutics Market Size & Share Analysis - Mordor Intelligence
4. Clinical Trials Market Size, Share & Analysis Report, 2024-2033 - Nova One Advisor
5. Clinical Overview for Soltamox (tamoxifen citrate) oral solution - Soltamox.com