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
Estrogen Receptor Positive	5
HER2/Neu Negative	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

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

Soltamox: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 29, 2026

What is Soltamox and what do current clinical signals indicate?

Soltamox is a prescription oncology drug candidate referenced in commercial and clinical contexts as tamoxifen / selective estrogen receptor modulation related. Public clinical-trial visibility for “Soltamox” as a distinct brand/entity is limited and fragmented across registries, sponsor pages, and local regulatory feeds. As a result, a clean, single-tracked clinical narrative (global phase progression, completed milestones, enrollment status, and readouts) cannot be established from reliably citable public sources.

Clinical-trials update (registry-level): No consolidated, citable dataset is available here that ties “Soltamox” to a unique set of trials (NCT/EudraCT identifiers), phases, endpoints, enrollment counts, and dates with sufficient completeness to support a market-linked projection.

What is the competitive and market framework Soltamox must fit?

Tamoxifen is an established, mature medicine across multiple oncology indications. Any “Soltamox” launch and growth profile is therefore driven less by therapeutic novelty and more by:

• Patent and exclusivity posture (API or formulation, salts, polymorphs, fixed-dose combinations, or geographic protection)
• Pricing and reimbursement access (brand vs generic pathway)
• Competitive intensity from off-patent tamoxifen and substitute SERMs and aromatase inhibitors depending on indication and line of therapy

Market structure for SERM-based therapy

For business planning, the addressable market is not “tamoxifen overall” but the subset where a SERM is standard and where Soltamox can win prescription volume:

• Breast cancer (adjuvant and prevention settings) where tamoxifen remains used
• Hormone receptor-positive disease where SERMs compete with aromatase inhibitors by menopausal status and guideline preference
• Treatment continuity and switching where brand switching depends on payer policies and tolerability narratives

Key commercial reality: off-patent competitive baseline

The dominant pricing force is generic tamoxifen. A brand-labeled “Soltamox” must differentiate through one or more of:

• Better tolerability or adherence in a distinct formulation
• Proven non-inferiority in a regulatory strategy
• Better payer access through discounts and evidence packages
• Geographic exclusivity via local patent families

What demand, pricing, and share assumptions support a projection?

A credible projection requires input on:

• Indication mix and label geography
• Forecasted time-to-launch and prescribing ramp
• Pricing relative to generic tamoxifen
• Generic erosion trajectory and tender dynamics

No citable launch status or labeling timeline for Soltamox exists in the available material for this response. Without label scope and regulatory timeline, a numerical projection would be fabricated.

Projection outcome that can be stated without fabrication: A projection cannot be produced with integrity because the necessary inputs (trial endpoints and regulatory milestones tied to the specific “Soltamox” entity, plus launch and reimbursement facts) are not available in the sourced record.

What patent, exclusivity, and regulatory path considerations matter most for Soltamox?

For an established MOA SERM like tamoxifen, commercial upside comes from exclusivity around:

• Formulations (controlled-release, particle engineering, improved bioavailability)
• Combinations (fixed-dose combinations with other oncology agents)
• Companion diagnostics or patient stratification (if tied to a new label)
• Manufacturing process (process patents for specific yield, purification, or polymorphic control)
• Geographic patent coverage (country-by-country expiry and enforcement strength)

Without a disclosed patent map, application numbers, jurisdiction-specific expiry dates, and regulatory filing status for the named product “Soltamox,” exclusivity analysis cannot be completed in a way that supports a market projection.

---

Key Takeaways

• Clinical trials: A complete, citable “Soltamox” clinical-trial update cannot be produced from a consolidated public record in this response.
• Market analysis: The relevant market is constrained by the mature tamoxifen baseline and generic competition; Soltamox’s growth depends on label scope, formulation or combination differentiation, pricing, and reimbursement access.
• Projection: A numerical market forecast cannot be generated without verified launch, label, exclusivity, and trial-to-approval linkage for the specific Soltamox entity.

---

FAQs

1) Is Soltamox a new molecular entity or an existing MOA brand?

Soltamox is referenced in contexts associated with tamoxifen-class therapy. A definitive classification as a new chemical entity versus a brand/formulation of an existing MOA is not supported by a consolidated, citable source set here.

2) What clinical endpoints would most affect a market projection for a SERM candidate?

Overall response rate is typically less central than in early-stage settings; in breast cancer, endpoint selection usually hinges on recurrence endpoints, disease-free survival proxies, safety/tolerability, and non-inferiority comparisons to standard-of-care tamoxifen.

3) How do generic tamoxifen and tendering dynamics affect Soltamox pricing power?

Generic penetration usually compresses price. A branded Soltamox must win volume through payer agreements, evidence packages, or differentiation that sustains premium pricing.

4) Which exclusivity types most plausibly protect a tamoxifen-based product?

Formulation patents, combination patents, process patents, and geographic enforcement strength generally drive the protection strategy more than MOA novelty.

5) What is the biggest gating item for forecasting Soltamox revenues?

A verified label and launch timeline tied to specific clinical evidence for the named product, plus confirmed pricing and reimbursement positioning.

---

References

[1] ClinicalTrials.gov. (n.d.). Database search results for “Soltamox” (accessed 2026-04-29). https://clinicaltrials.gov/
[2] EMA. (n.d.). European public assessment reports and procedure database (accessed 2026-04-29). https://www.ema.europa.eu/
[3] U.S. FDA. (n.d.). Drugs@FDA database (accessed 2026-04-29). https://www.accessdata.fda.gov/scripts/cder/daf/