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.

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

Condition MeSH

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

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

Clinical Trials Update, Market Analysis, and Projection for Taxotere

Last updated: October 28, 2025

Introduction

Taxotere (docetaxel) is a chemotherapy drug developed by Sanofi that has played a pivotal role in the treatment of various cancers, notably breast, non-small cell lung, prostate, gastric, and head and neck cancers. Since its FDA approval in 1996, Taxotere has maintained a significant position in oncology, fueled by ongoing clinical trials, expanding indications, and evolving market dynamics. This report provides a comprehensive update on the latest clinical trial landscape, market analysis, and projections for Taxotere, emphasized by recent regulatory and competitive developments.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen several pivotal clinical trials for Taxotere, primarily focusing on new combination therapies, indications, and biomarker-driven approaches:

• Breast Cancer:
  Numerous phase III trials confirm Taxotere's efficacy in early and metastatic breast cancer. The ongoing SWOG S0819 trial, for example, investigates the combination of Taxotere with immune checkpoint inhibitors, aiming to enhance immunogenic responses.

• Non-Small Cell Lung Cancer (NSCLC):
  Trials continue to evaluate Taxotere in combination with targeted therapies like bevacizumab and newer immunotherapies, such as PD-1/PD-L1 inhibitors, aiming to improve survival outcomes.

• Gastric and Esophageal Cancers:
  Phase II/III trials are assessing Taxotere-based regimens with emerging agents like ramucirumab, with some studies reporting promising progression-free survival (PFS) improvements.

• Biomarker-Driven Trials:
  Efforts are underway to identify predictive biomarkers for Taxotere responsiveness, including nucleotide polymorphisms and tumor microenvironment profiles, potentially enabling more tailored therapy approaches.

Regulatory and Labeling Updates

While no recent approvals have expanded Taxotere’s indications significantly, Sanofi has been active in updating labeling to reflect emerging efficacy data and safety profiles. The company is also pursuing supplemental indications in gastric and head and neck cancers, subject to successful trial outcomes.

Safety and Adverse Events Monitoring

Continuous global pharmacovigilance underscores concerns about neutropenia, fluid retention, and neuropathy. Trials are exploring supportive care measures and dosing modifications to mitigate toxicity, with some recent studies indicating improved tolerability with prophylactic granulocyte colony-stimulating factors (G-CSF).

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Market Analysis

Market Size and Trends

The global oncology market is projected to reach approximately USD 250 billion by 2027, with chemotherapeutic agents accounting for a significant share. Taxotere's current market is estimated to be valued at around USD 1.2 billion annually, though this figure is pressure-tested by patent expirations, biosimilar entrants, and evolving treatment paradigms.

Competitive Landscape

• Patent Expiry and Biosimilars:
  Sanofi's patent exclusivity for Taxotere expired in multiple jurisdictions by 2019, leading to the entry of biosimilars such as Docetaxel Accord, Cinfa's Taxotere, and others in Europe, India, and emerging markets.

• Emergence of New Delivery Platforms:
  Liposomal and nanoparticle formulations aim to enhance targeted delivery, reduce toxicity, and expand indications.

• Other Chemotherapies and Targeted Agents:
  Taxane derivatives like Paclitaxel and nab-Paclitaxel, along with targeted agents such as CDK4/6 inhibitors, are eroding Taxotere’s market share, particularly in breast cancer.

Market Drivers and Challenges

Drivers:

• Expanding indications (e.g., gastric, head and neck cancers).
• Combination regimens with immunotherapies, potentially improving outcomes.
• Increasing global cancer prevalence, notably in emerging markets.

Challenges:

• Price erosion due to biosimilars and generics.
• Toxicity profiles prompting treatment modifications.
• Competition from newer targeted and immunotherapy agents with more favorable safety profiles.

Regional Market Dynamics

• North America:
  The largest market, driven by robust clinical adoption, though facing significant biosimilar competition.

• Europe:
  Similar to North America, with strict regulatory environments favoring biosimilar uptake.

• Asia-Pacific:
  Emerging market growth due to increasing cancer burden, expanding healthcare infrastructure, and lower drug prices.

• Latin America and Africa:
  Limited access to high-cost chemotherapies, although sales may grow with increased healthcare investment.

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Market Projection

Forecast Period (2023-2030)

Analysts project the global Taxotere market will experience a compound annual growth rate (CAGR) of approximately 2.5% to 3% over the next decade, driven primarily by:

• Emerging Indications:
  Trials and regulatory submissions for gastric, head and neck, and prostate cancers could sustain or somewhat elevate market size.

• Biosimilar Penetration:
  Though biosimilars reduce per-unit revenue, volume increases and price competition may mitigate revenue declines.

• Combination Therapies:
  The integration of Taxotere into multi-drug regimens, especially those involving immunotherapies, could improve overall sales by expanding its clinical utility.

• Global Disease Burden:
  Rising cancer prevalence, particularly in Asian markets, offers substantial growth opportunities.

Scenario Analysis

• Optimistic Scenario:
  Successful approval of new indications combined with effective repositioning in immunotherapy combinations could boost annual revenues by 10-15% in select markets.

• Pessimistic Scenario:
  Faster and more aggressive biosimilar price erosion coupled with competition from targeted therapies could reduce revenues to pre-2015 levels, approximately USD 900 million annually.

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Regulatory and Commercial Outlook

Sanofi’s strategic focus appears to be on maintaining a competitive edge through clinical trial expansion and label updates. Innovations in formulation and combination regimens are promising routes to sustain relevance, especially in a landscape shifting towards personalized medicine.

Regulatory agencies like the FDA and EMA remain vigilant on safety concerns but continue to endorse the use of Taxotere in approved indications. Efforts to secure approvals in additional indications depend heavily on trial outcomes, which are anticipated over the next 2-4 years.

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Key Takeaways

• Clinical Trial Landscape:
  Ongoing trials aim to enhance Taxotere's efficacy through combination therapies with immunotherapy agents and biomarker-driven patient selection, potentially broadening its use.

• Market Competition:
  Biosimilar entries have exerted downward pressure on pricing, but expansion into new indications and combination therapies may offset some revenue decline.

• Market Dynamics:
  Despite challenges, the global rise in cancer prevalence and ongoing clinical developments suggest a steady, albeit slower, market presence for Taxotere up to 2030.

• Strategic Outlook:
  Sanofi’s investment in clinical trials and label updates can preserve taxotere’s relevance. Focusing on combination regimens and emerging indications remains paramount.

• Regulatory Environment:
  Evolving approval pathways for new indications and formulations will be critical for future growth.

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FAQs

1. What are the primary indications for Taxotere today?
Taxotere is primarily indicated for breast cancer (adjuvant, metastatic, and locally advanced), non-small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma, and head and neck cancers, depending on regional approvals.

2. How are biosimilars impacting Taxotere's market?
Biosimilars significantly reduce pricing power and market share in mature markets like Europe and North America. They offer cost advantages but face challenges regarding interchangeability and clinical acceptance.

3. Are there any promising new indications for Taxotere under clinical investigation?
Yes, trials are exploring its role in combination with immunotherapies in lung and breast cancers, and expanding into gastric and head/neck cancers, with potential regulatory approvals in the coming years.

4. What are the major safety concerns associated with Taxotere?
Neutropenia, fluid retention, peripheral neuropathy, and alopecia are primary adverse events. Strategies such as supportive care and dose adjustments are common to mitigate toxicity.

5. How does the future look for Taxotere in the oncology market?
While facing headwinds from biosimilars and newer targeted agents, ongoing clinical trials, potential label expansions, and strategic formulation efforts may help sustain its role, particularly in combination therapies and emerging indications.

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References

[1] U.S. Food and Drug Administration. Taxotere (docetaxel) prescribing information. 2022.
[2] GlobalData. Oncology Market Analysis and Forecast, 2023.
[3] Sanofi. Regulatory submissions and updates on Taxotere, 2022.
[4] MarketWatch. Oncology drug market trends, 2022.
[5] ClinicalTrials.gov. Ongoing Trials for Docetaxel and Taxotere, 2023.