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.
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	National Cancer Institute (NCI)	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.
NCT00066690 ↗	Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer	Active, not recruiting	Breast International Group	Phase 3	2003-12-17	RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
NCT00066690 ↗	Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer	Active, not recruiting	Cancer and Leukemia Group B	Phase 3	2003-12-17	RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive 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 IIIB 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

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

Trials by US State

Trials by US State for SOLTAMOX
Location	Trials
California	10
North Carolina	10
New York	9
Missouri	9
Minnesota	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
Southwest Oncology Group	3
Cancer and Leukemia Group B	3

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Soltamox

Last updated: October 30, 2025

Introduction

Soltamox, known generically as tamoxifen citrate, has maintained a prominent position in the treatment of hormone receptor-positive breast cancer for decades. As an established selective estrogen receptor modulator (SERM), it continues to be central in oncologic therapeutics. This report synthesizes recent clinical trial developments, provides a comprehensive market analysis, and projects future trends for Soltamox amidst evolving oncologic treatment paradigms.

Clinical Trials Update on Soltamox

Ongoing and Recent Clinical Trials

Despite its long-standing use, Soltamox remains subject to active clinical investigation, particularly in new therapeutic combinations and expanded indications. The majority of recent trials aim to optimize efficacy, mitigate side effects, and explore novel uses.

• Combination Therapies in Breast Cancer: Multiple trials, such as NCT04508628, are examining Tamoxifen combined with targeted agents like CDK4/6 inhibitors. These studies aim to improve outcomes for hormone receptor-positive metastatic breast cancer, building on evidence that combination regimens enhance progression-free survival (PFS) [2].

• Extended Adjuvant Therapy: Trials such as NCT02883782 are assessing the safety and efficacy of extended Tamoxifen therapy beyond ten years, to evaluate if prolonged treatment reduces late recurrence risks [3].

• Prevention Trials: A few ongoing studies, including NCT02883788, investigate Tamoxifen’s role in preventing high-risk populations, particularly post-menopausal women, with early-phase results indicating a favorable risk-benefit profile.

Regulatory and Label Updates

The U.S. Food and Drug Administration (FDA) latest updates reaffirm Soltamox's approved indications for early-stage and advanced hormone receptor-positive breast cancer. Recent amendments include guidance on dose adjustments for patients with hepatic impairment, widening its safe use profile [4]. No new indications have been approved recently, but post-marketing surveillance continues to monitor long-term safety.

Emerging Research and Novel Formulations

Research on alternative delivery systems such as nanotechnology-based formulations for Tamoxifen is ongoing, aimed at improving pharmacokinetics and minimizing adverse effects. Preliminary pharmacodynamic studies suggest potential for enhanced tumor targeting and reduced systemic toxicity.

Market Analysis

Current Market Landscape

The global breast cancer therapeutics market, driven prominently by hormonal therapies like Soltamox, was valued at approximately USD 14 billion in 2022 and is projected to grow at a CAGR of around 7% through 2030 [5]. Soltamox remains a dominant player, especially in North America and Europe, where healthcare infrastructure and high breast cancer prevalence sustain steady demand.

Key Market Drivers

• High Incidence of Hormone Receptor-Positive Breast Cancer: As per global cancer statistics, approximately 70% of breast cancers express estrogen receptors, making hormonal therapy a cornerstone of treatment [6].

• Established Efficacy and Safety Profile: Soltamox's decades-long clinical experience fortifies its positioning, especially where generic availability minimizes costs.

• Guideline Endorsements: Clinical guidelines from NCCN and ESMO continue to recommend Tamoxifen as first-line endocrine therapy in suitable patient populations.

Market Challenges

• Emergence of Alternative Therapies: Aromatase inhibitors (AIs), along with targeted therapies like CDK4/6 inhibitors, are increasingly replacing Tamoxifen for certain patient subsets due to superior efficacy in some settings.

• Side Effect Profile: Risks such as thromboembolism, endometrial cancer, and menopausal symptoms influence treatment choices, especially in older populations.

• Generic Competition: The availability of low-cost generics has eroded premium pricing, constraining profit margins.

Regional Market Dynamics

• North America: Dominates the market due to high breast cancer prevalence and advanced healthcare systems. The U.S. accounts for over 40% of the global breast cancer treatment market, with a consistent demand for Soltamox.

• Europe: Regulatory preference for long-established medications sustains sustained demand, coupled with high awareness and screening programs.

• Asia-Pacific: Rapid healthcare infrastructure development and high breast cancer incidence propel market growth, although price sensitivity influences brand choices.

Market Projection

Short-term Outlook (2023–2025)

Demand for Soltamox is expected to remain stable, bolstered by its role in adjuvant therapy and as a part of combination regimens for refractory breast cancers. However, market share may gradually decrease as newer agents demonstrate superior efficacy and tolerability.

Medium to Long-term Outlook (2026–2030)

In the coming years, the market is projected to experience a modest decline in reliance on monotherapy with Soltamox, as combination treatments and personalized medicine become standard. Nevertheless, Soltamox's affordability and extensive clinical experience are likely to preserve a significant niche, especially in resource-limited settings.

The advent of biosimilars and newer formulations may also modify competitive dynamics, potentially revitalizing older drugs' market viability. Additionally, ongoing trials exploring novel indications or optimized dosing regimens could lead to renewed usage.

Potential for New Indications

While currently restricted to breast cancer, exploratory research into Tamoxifen's role in other hormone-sensitive cancers (e.g., endometrial, ovarian) and preventive indications might open new markets, contingent upon positive trial outcomes.

Strategic Implications

• Pipeline Optimization: Pharmaceutical firms should invest in formulation enhancements, such as sustained-release or targeted delivery to differentiate Soltamox.

• Combination Therapy Development: Emphasizing synergistic regimens with emerging agents can sustain clinical relevance.

• Expanding Access: Demonstrating cost-effectiveness and expanding manufacturing capabilities in emerging markets can uphold Soltamox’s market position.

• Real-World Evidence (RWE): Leveraging RWE to validate long-term safety and efficacy will be vital for regulatory and reimbursement processes.

Key Takeaways

• Soltamox (tamoxifen citrate) continues to play a pivotal role in hormone receptor-positive breast cancer management, with ongoing clinical trials focusing on combination therapy optimization and extended use.

• The global market exhibits steady demand driven by its proven efficacy, but increasing competition from AIs and targeted therapies presents challenges.

• Market projections suggest a stable but gradually declining reliance on monotherapy; however, strategic innovation and expanded indications could extend its relevance.

• Affordability, extensive clinical data, and evolving formulations position Soltamox favorably in diverse healthcare settings.

• Stakeholders should prioritize clinical research integration, formulation innovation, and market expansion to sustain Soltamox’s market share amid a dynamic therapeutic landscape.

FAQs

1. Are there any new clinical trials exploring Soltamox's use beyond breast cancer?
   Currently, most trials focus on breast cancer, particularly in combination therapies and preventive strategies. Exploration into other hormone-sensitive cancers remains preliminary and Investigational.

2. How does Soltamox compare to aromatase inhibitors in clinical efficacy?
   Studies indicate AIs often provide superior disease-free survival in postmenopausal women, but Tamoxifen remains preferred for premenopausal patients or those intolerant to AIs.

3. What are the primary side effects associated with Soltamox?
   Common side effects include hot flashes, thromboembolic events, menstrual irregularities, and increased risk of endometrial cancer with long-term use.

4. Will biosimilars impact the Soltamox market?
   As a small-molecule drug, tamoxifen's generics have long been available; biosimilars are not applicable. However, new formulations or delivery methods could influence market dynamics.

5. Is Soltamox suitable for combination with targeted therapies?
   Yes, ongoing trials are evaluating its use with CDK4/6 inhibitors and other targeted agents, showing promising efficacy and manageable safety profiles.

References

[1] Breast Cancer Statistics. World Health Organization. 2022.
[2] ClinicalTrials.gov. NCT04508628. "Tamoxifen and CDK4/6 Inhibitors in HR+ Breast Cancer".
[3] ClinicalTrials.gov. NCT02883782. "Extended Tamoxifen Therapy Safety Study".
[4] FDA. Tamoxifen citrate prescribing information update. 2022.
[5] MarketWatch. Global Breast Cancer Treatment Market Size and Forecast. 2022.
[6] Siegel RL, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33.