CLINICAL TRIALS PROFILE FOR TAXOTERE

505(b)(2) Clinical Trials for TAXOTERE

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 Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Sanofi	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
New Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Cancer Research Network	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
New Combination	NCT02616848 ↗	Safety and Tolerability of Everolimus in Combination With Eribulin in Triple-negative Breast Cancers	Unknown status	Istituti Ospitalieri di Cremona	Phase 1	2015-11-01	Treatment of triple negative breast cancer (TNBC) relies heavily on different regimes of chemotherapeutic agents but remains one of the most challenging subtypes to treat because of the lack of specific therapies. Despite being sensitive to chemotherapy, many women with TNBC relapse quickly, developing locoregional recurrence or visceral metastasis. Toxicity and chemotherapy resistance are still major limitations in the treatment of patients with TNBC. Despite current trend of targeted therapy development, cytotoxic agents are a mainstay of treatment of patients with breast cancer. Further research into new combination of different compounds is needed in order to maximise benefit, whilst minimising toxicity. The phosphoinositide 3-kinase (PI3K) pathway is associated with resistance to a variety of anti-tumor agents. This has been described pre-clinically with cytotoxic chemotherapeutic agents with varying mechanisms of action including taxanes, and DNA-damaging agents. In the clinic, activated PI3K in tumors has been correlated with decreased response to therapy and worse clinical outcomes. The recent biological findings suggest that a PI3K/mammalian target of rapamycin (mTOR) inhibitors may increase the efficacy of chemotherapeutic agents which are considered standard of care (SOC) for the treatment of several solid tumors. The study by the Unitaed state Oncology Research of Huston and the Sarah Cannon Cancer Center randomized 1830 patients with high risk breast cancer to the standard adjuvant treatment with adriamicin cyclophosphamide followed by paclitaxel versus the experimental adjuvant treatment with adriamicin taxotere (AT) followed by paclitaxel. At 5-years of follow up, the AT followed by paclitaxel produced significantly better overall survival (p=0.054) and improved disease free survival (DFS) (p=0.19). Among TNBC patients both DFS (74% versus 79%, p=0.1) and overall survival (OS) (79% versus 84%, p=0.037) were better in experimental arm. However, the main reasons for patients being taken off study treatment were toxicity (85 patients in the control arm and 128 in the experimental arm) and consent withdrawal (18 patients in the control arm and 30 patients in the experimental arm). For this reason, research into alternatives has intensified, thus resulting in the discovery and development of new compounds with a more tolerable profile as compared with paclitaxel. Among the total of 762 patients enrolled into Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389 (EMBRACE) trial, 19% had TNBC. Of note, eribulin was most effective in hormone receptor-negative patients and in TNBC patients, who had a 29% risk reduction. Treatment with eribulin was well tolerated. Neutropenia, leucopenia, peripheral neuropathy, and asthenia/fatigue were the most common adverse events reported at Common Terminology Criteria for Adverse Events (CTCAE) grades 3 and 4. Neutropenia was the most common adverse events reported at CTCAE grade 4 in the eribulin group (24.1%). Based on findings to date, eribulin is an attractive agent, and its role in combination with new compounds such as everolimus deserves further investigations. Their combination might lead to more profound effects on tumor cell biology of triple negative metastatic breast cancer. During the course of the trial, dose reductions for each combination will be permitted in patients who cannot tolerate the starting dose

All Clinical Trials for TAXOTERE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002662 ↗	Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer	Completed	Aventis Pharmaceuticals	Phase 3	1994-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than docetaxel for breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.
NCT00002707 ↗	Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed	Completed	National Cancer Institute (NCI)	Phase 3	1995-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.
NCT00002707 ↗	Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed	Completed	NSABP Foundation Inc	Phase 3	1995-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.
NCT00002775 ↗	Docetaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer	Unknown status	Herbert Irving Comprehensive Cancer Center	Phase 1/Phase 2	1998-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel and estramustine in treating patients who have metastatic prostate cancer.
NCT00002825 ↗	Docetaxel in Treating Children With Recurrent Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 2	1997-01-01	Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Clinical Trial Conditions for TAXOTERE

Condition Name

Condition Name for TAXOTERE
Intervention	Trials
Breast Cancer	114
Prostate Cancer	86
Non-Small Cell Lung Cancer	39
Lung Cancer	37

Condition MeSH

Condition MeSH for TAXOTERE
Intervention	Trials
Breast Neoplasms	178
Carcinoma, Non-Small-Cell Lung	160
Lung Neoplasms	152
Prostatic Neoplasms	147

Clinical Trial Locations for TAXOTERE

Trials by Country

Trials by Country for TAXOTERE
Location	Trials
China	98
Japan	78
France	76
Germany	59
Australia	56

Trials by US State

Trials by US State for TAXOTERE
Location	Trials
Texas	160
California	140
Ohio	120
Florida	111
New York	111

Clinical Trial Progress for TAXOTERE

Clinical Trial Phase

Clinical Trial Phase for TAXOTERE
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	4
PHASE1	1

Clinical Trial Status

Clinical Trial Status for TAXOTERE
Clinical Trial Phase	Trials
Completed	413
Terminated	117
Recruiting	77

Clinical Trial Sponsors for TAXOTERE

Sponsor Name

Sponsor Name for TAXOTERE
Sponsor	Trials
National Cancer Institute (NCI)	183
Sanofi	82
M.D. Anderson Cancer Center	38

Sponsor Type

Sponsor Type for TAXOTERE
Sponsor	Trials
Other	790
Industry	464
NIH	184

Last updated: May 22, 2026

TAXOTERE (docetaxel) clinical trials update, market analysis, and projection (2026-2032)

Executive summary: TAXOTERE (docetaxel) remains a core chemotherapy backbone in multiple solid tumors. Clinical activity is concentrated in label-expansion studies, combination regimens (often with immuno-oncology or targeted agents), and regimen optimization (neoadjuvant/adjuvant and dosing/schedule work). Commercial outlook is shaped by (1) continued reliance in breast, gastric/GEJ, prostate, lung, and head-and-neck cancers, (2) intensifying competitive pressure from drug-drug combinations that can reduce chemo share, and (3) supply and cost dynamics typical for multi-source cytotoxic oncology drugs. From a patent/exclusivity perspective, TAXOTERE’s original brand exclusivity has long ended in most major markets, shifting the market toward generics and authorized/parallel supply rather than brand price growth. Forecast demand growth is therefore expected to be volume- and induction-driven rather than value-driven.

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What is TAXOTERE (docetaxel) used for and what are the latest clinical-trial themes?

Short answer: TAXOTERE is used across breast, gastric/GEJ, prostate, lung, and head-and-neck cancers, with clinical trial emphasis on combination sequencing, biomarker-stratified enrollment, and moving docetaxel into earlier lines (neoadjuvant/adjuvant) and multi-modality regimens.

Key therapeutic areas and high-frequency regimen settings

• Breast cancer
  • Metastatic disease combinations (commonly with platinum, HER2 agents where applicable, and immunotherapy in selected protocols)
  • Neoadjuvant/adjuvant docetaxel-containing regimens as part of multi-agent chemotherapy frameworks
• Gastric cancer and gastroesophageal junction (GEJ)
  • Docetaxel-based chemotherapy backbones as second-line and later-line standards in many settings
  • Trials focused on sequencing with immunotherapy and anti-angiogenic agents
• Prostate cancer
  • Docetaxel in metastatic castration-sensitive and castration-resistant contexts (often with androgen axis therapies)
  • Trials exploring optimal induction duration and combinations to delay progression
• Non-small cell lung cancer (NSCLC)
  • Docetaxel commonly appears in later-line chemotherapy settings and in combination strategies when immunotherapy is integrated
• Head and neck squamous cell carcinoma (HNSCC)
  • Docetaxel combinations in locally advanced disease frameworks and salvage contexts

Clinical-trial “update” pattern seen in docetaxel programs

Most current docetaxel trials cluster into:

1. Combination therapy optimization (IO + chemo, targeted agents + chemo)
2. Schedule comparisons (dose density, cycle length, partner drug timing)
3. Biomarker gating (PD-L1, HRD-like proxies, molecular signatures, immunophenotyping for response enrichment)
4. Early-stage consolidation (neoadjuvant intensification and pathologic response endpoints)

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What are the latest TAXOTERE clinical trials by phase, population, and endpoint?

Short answer: Current docetaxel trial activity is dominated by randomized combination comparisons and regimen sequencing studies, with endpoints that skew toward progression-free survival (PFS), overall survival (OS), and pathologic complete response (pCR) in breast and other resectable settings.

Featured endpoint types by indication

• Metastatic settings: PFS, OS, objective response rate (ORR), time to treatment failure
• Neoadjuvant/adjuvant settings: pCR, event-free survival (EFS), OS
• Safety-anchored comparisons: febrile neutropenia incidence, dose modification rates, cumulative toxicity signals

How to read “updates” in docetaxel trials

Docetaxel is rarely the only “variable.” Trial updates typically come from:

• A partner drug moving into the phase (IO or targeted agent adoption)
• Adjusted docetaxel schedule to manage toxicity while preserving efficacy
• Stratification changes tied to biomarker work

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Which TAXOTERE trials are most likely to change practice and label?

Short answer: Practice-changing updates generally come from phase 3 trials that improve OS or EFS in specific combinations, or from neoadjuvant trials that convert to higher pCR rates without prohibitive safety.

Label-change pathways for docetaxel-combination trials

• New line of therapy (e.g., earlier use with a new partner)
• New combination approval (partner drug gets approved with docetaxel or in a docetaxel-based regimen)
• Expanded biomarker-defined indications (less common, but increases specificity)
• New dosing/schedule regimen claims (fewer outcomes claims, more regimen-level differentiation)

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When do TAXOTERE clinical trials report results and what is the near-term evidentiary timeline?

Short answer: The near-term evidentiary window for docetaxel typically aligns with readouts at major oncology congresses and subsequent journal publications, with the highest probability of actionable updates coming from phase 3 combination regimens in breast, gastric/GEJ, prostate, and NSCLC.

Practical timeline framework for investors and planners

• 0 to 12 months: interim analyses and secondary endpoint reporting, safety updates, subgroup findings
• 12 to 24 months: primary endpoint readouts for phase 3 combination studies
• 24 to 36 months: regulatory label reflections if partner and regimen are aligned with approval strategy

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What does the TAXOTERE market look like today by geography and indication?

Short answer: TAXOTERE’s market is driven by multi-indication oncology chemotherapy usage rather than a single dominant program. Demand is resilient but increasingly price-pressured by generics and supply competition. Geographic concentration follows major advanced cancer incidence and reimbursement systems, with the U.S., EU5, and Japan the key revenue pools.

Indication-level drivers that shape market share

• Breast cancer: ongoing chemo backbone in multiple disease phases
• Gastric/GEJ: docetaxel-based approaches retain relevance in later lines despite immunotherapy reshaping standards
• Prostate: docetaxel remains a landmark chemo component when combined with androgen axis therapies or integrated into mHSPC/cRPC strategies
• Lung and HNSCC: chemo combinations remain important, particularly when IO integration changes regimen timing

Supply and pricing structure

• Docetaxel is widely multi-sourced in most mature markets.
• Market value growth depends more on volume durability, guideline preference, and contracting dynamics than on brand premium.

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How strong is the competitive landscape for TAXOTERE versus other chemotherapy backbones?

Short answer: Docetaxel competes primarily in regimens, not as a standalone molecule. Competition comes from:

• Alternative chemotherapies with improved tolerability profiles
• Combo regimens that can substitute part of chemo share
• Immunotherapy and targeted therapy utilization that can delay or reduce chemo in some lines

Direct competitive cohorts

• Other taxanes: paclitaxel and nab-paclitaxel, docetaxel schedule variants
• Platinums: cisplatin and carboplatin partner roles
• Antimetabolites and topoisomerase agents: regimen alternatives in specific tumor types
• Chemo-light IO strategies: in some populations where response durability or biomarkers reduce chemo need

“Docetaxel share” risk factors

• Toxicity substitution (neutropenia and fatigue profiles drive regimen choice)
• Increased IO adoption can reduce cycles
• Local formulary decisions and payer step edits can shift to lower-cost equivalents

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What are the market risks and discontinuation dynamics affecting TAXOTERE demand?

Short answer: Market risk is largely payer and practice driven rather than molecule discontinuation. Demand can soften when:

• Guidelines move to IO-led regimens that shorten chemotherapy use
• New targeted regimens replace chemo in biomarker-positive disease
• Cost pressures drive substitution toward the lowest-cost docetaxel product

Key risk map by stakeholder

• Hospitals/oncology groups: cost contracting and toxicity management
• Payers: utilization controls, biosimilar-style or generic substitution logic
• Clinicians: efficacy evidence and toxicity burden relative to alternatives
• Supply chains: manufacturing and cold-chain logistics for oncology injectables

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What are TAXOTERE pricing and reimbursement dynamics under generic competition?

Short answer: In mature markets, the practical market pricing for docetaxel is set by generic competition. Brand retention depends on tender pricing, contract rebates, and product access. Margin and forecast value growth are typically limited without exclusivity differentiation.

Commercial levers that still matter despite generic supply

• Acquisition price and administered cost
• Distribution reliability and hospital formulary status
• Support services for procurement, nursing protocols, and adverse event management

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What is the patent estate for TAXOTERE, and when does exclusivity end?

Short answer: TAXOTERE’s core active ingredient and earliest composition and formulation exclusivities are long expired. In most geographies, remaining patent leverage is mainly around specific formulations, delivery systems, and particular combinations or methods, if any, with generic market entry largely enabled for years.

How generic entry typically happened for docetaxel brands

• Broad chemical and early composition coverage expired years ago
• Later differentiation, where present, is usually formulation-specific (e.g., excipient and solvent systems) or method-of-use related
• Current market is therefore structurally generic-dominant in many countries

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What is the Orange Book status of TAXOTERE (docetaxel) in the U.S.?

Short answer: TAXOTERE appears as a listed drug in the U.S. FDA Orange Book system, but U.S. competitive dynamics are governed by generic listings and expiration of most brand exclusivities.

Orange Book-driven implications

• Generic availability is common for docetaxel
• Remaining legal leverage, if any, is narrow to specific product- and method-level patents tied to listed NDAs/ANDA entries

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What Paragraph IV challenges or ANDA litigation affects TAXOTERE?

Short answer: For docetaxel, litigation is typically associated with older ANDA scenarios and formulation-specific patent assertions rather than new foundational exclusivity. Current market impact is more about commercial supply and contracting than ongoing brand-facing exclusivity disputes.

Typical litigation patterns for multi-source cytotoxics

• Patent assertions tied to formulation components, manufacturing controls, or packaging
• Settlements that lead to delayed launches for particular strengths or presentations

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What formulation patents exist for docetaxel products, and do they block generic substitution?

Short answer: Formulation and process patents may affect specific product presentations, but they usually do not prevent generic substitution broadly across all docetaxel uses once key exclusivities have expired.

Formulation patent categories that can matter

• Solvent system and excipient composition claims
• Particle size, concentration stability, and manufacturing process control
• Packaging and reconstitution instructions that tie to product stability

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How do neoadjuvant and adjuvant studies with docetaxel affect long-term demand?

Short answer: Earlier-stage use can extend docetaxel volume because it shifts chemo utilization from metastatic rescue settings into potentially broader curative-intent pathways, but uptake depends on trial results and guideline adoption.

Demand durability logic

• If docetaxel becomes embedded in standard neoadjuvant regimens for a growing set of tumor types, volume can stay resilient even as later-line standards evolve.
• If neoadjuvant regimens move toward targeted/IO-based pathways that reduce chemo cycles, chemo demand can soften.

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What is the biosimilar and biologics risk profile for TAXOTERE?

Short answer: There is no biosimilar angle for docetaxel itself because it is a small-molecule chemotherapy. Risk comes from biologics and targeted therapies that can replace chemo in certain lines or biomarker-defined subsets.

Practical competitive impact

• IO combinations can reduce the number of chemo cycles needed per course
• Targeted therapy uptake can move chemo down the line in selected patients

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How strong is the patent-litigation barrier to new generic entry for docetaxel today?

Short answer: The barrier is usually low for broad docetaxel product entry due to long-expired core exclusivity. Remaining barriers are presentation- and patent-specific and generally do not stop generic chemotherapy substitution across the market.

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Market projection for TAXOTERE (2026-2032): base case, downside, and upside drivers

Short answer: Projection depends on volume durability in standard regimens versus pricing compression and chemo share erosion from IO and targeted therapies. The most likely scenario is modest market value growth driven by stable volumes and slight mix shifts, with real value held back by generic pricing.

Forecast drivers (what increases or decreases the curve)

Upside drivers

• Uptake of docetaxel-containing regimens in earlier lines where chemo is still standard
• Continued guideline support in gastric/GEJ, prostate, and breast chemo backbones
• Stable clinical safety profile allowing full-dose delivery compared with more toxic alternatives

Downside drivers

• Substitution away from chemo in IO-led regimens that reduce cycles
• Increased preference for chemo-free or chemo-light strategies in biomarker-defined subsets
• Aggressive pricing by generics and parallel supply leading to further value compression

Projection structure (actionable planning framework)

• Volume: driven by indication prevalence, line-of-therapy patterns, and regimen inclusion rates
• Value: driven by average net price after rebates and contracting
• Mix: driven by course length, setting (adjuvant vs metastatic), and strength/presentation utilization

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Which companies supply TAXOTERE and what do they control commercially?

Short answer: The market is typically supplied by multiple generic and authorized manufacturers in major regions. Commercial control is often exercised via tender participation, hospital contracts, and distribution reliability rather than exclusivity.

How to map competitive power

• Hospital formulary access and GPO contracts
• Lead-time reliability and supply continuity
• Support for administration protocols and adverse event management
• Portfolio breadth across strengths and presentations

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Key Takeaways

• TAXOTERE remains a central chemotherapy backbone with clinical trial activity focused on combination optimization, regimen sequencing, and earlier-line integration.
• Market demand is structurally resilient but value growth is constrained by generic competition and contracting dynamics.
• Near-term clinical readouts that improve OS/EFS in specific docetaxel combination contexts are the most likely to shift standard-of-care and impact volume.
• Forecasts for 2026-2032 should treat TAXOTERE as a generic-dominant market where growth is driven by volume and regimen inclusion, not brand pricing power.

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FAQs

1) What cancers have the highest docetaxel utilization and where is growth most likely?
Breast, gastric/GEJ, prostate, and lung remain the highest-utilization settings; growth potential is most sensitive to earlier-line adoption in neoadjuvant/adjuvant frameworks.

2) Do docetaxel combination trials with immunotherapy increase demand for TAXOTERE?
They can increase overall chemo exposure if docetaxel remains part of the backbone, but IO-led chemo reductions can also decrease cycles. Net impact depends on regimen sequencing and guideline adoption.

3) What dosing schedules for docetaxel are most common in current practice and trials?
Practice and trials typically compare standard q21-day docetaxel frameworks with schedule modifications tied to toxicity management and partner drug administration.

4) Are there any remaining meaningful patent barriers to generic docetaxel in major markets?
Broad barriers are generally minimal given long-expired core exclusivities; any remaining barriers are likely narrow to formulation/process or specific product presentations.

5) How do supply and contracting dynamics affect TAXOTERE market share more than clinical outcomes?
In mature markets, availability, tender pricing, and formulary placement often drive market share among interchangeable docetaxel products after exclusivity lapses.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. ClinicalTrials.gov. (n.d.). Search results for docetaxel (TAXOTERE) clinical trials. U.S. National Library of Medicine.
3. FDA. (n.d.). Drug trials snapshots: docetaxel. U.S. Food and Drug Administration.