You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 12, 2025

CLINICAL TRIALS PROFILE FOR TAXOTERE


✉ Email this page to a colleague

« Back to Dashboard


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
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Taxotere
Intervention Trials
Breast Neoplasms 177
Carcinoma, Non-Small-Cell Lung 160
Lung Neoplasms 152
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Taxotere

Trials by Country

Trials by Country for Taxotere
Location Trials
China 97
Japan 78
France 75
Germany 59
Australia 56
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Taxotere
Location Trials
Texas 160
California 140
Ohio 120
New York 111
Florida 110
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Taxotere

Clinical Trial Phase

Clinical Trial Phase for Taxotere
Clinical Trial Phase Trials
Phase 4 8
Phase 3 121
Phase 2/Phase 3 17
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Taxotere
Clinical Trial Phase Trials
Completed 413
Terminated 117
Recruiting 74
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Taxotere
Sponsor Trials
Other 787
Industry 461
NIH 184
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Taxotere (Docetaxel): Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction to Taxotere (Docetaxel)

Taxotere, also known as docetaxel, is a chemotherapy medication used in the treatment of various types of cancer, including breast, prostate, stomach, and non-small cell lung cancers. Here, we will delve into the current state of clinical trials involving Taxotere, analyze the market trends, and provide projections for its future growth.

Clinical Trials Update

Ongoing and Completed Trials

Clinical trials are a crucial part of the development and approval process for any drug, including Taxotere. Here are some notable trials:

  • Phase II Trial for Non-Small Cell Lung Cancer: An open randomized non-comparative phase II trial has been conducted to evaluate the efficacy of docetaxel alone and in combination with ZD1839 (Iressa) as second-line chemotherapy in patients with advanced or metastatic non-small cell lung cancer[1].

  • Phase III Trial for Prostate Cancer: A phase III trial is studying the combination of docetaxel and radium Ra 223 dichloride compared to docetaxel alone in treating patients with prostate cancer. This trial aims to determine the efficacy and safety of this combination therapy[4].

  • Phase III Trial for Head and Neck Squamous Cell Carcinoma: The EORTC 24971/TAX323 study demonstrated that the TPF regimen (Taxotere, cisplatin, and 5-FU) significantly improves both progression-free survival and overall survival compared to the standard PF regimen (cisplatin and 5-FU) in patients with inoperable, locally advanced head and neck squamous cell carcinoma[3].

Key Findings and Outcomes

  • The TPF regimen has shown significant improvements in both progression-free survival and overall survival for patients with head and neck squamous cell carcinoma, highlighting the efficacy of Taxotere in combination therapy[3].

  • In prostate cancer, docetaxel-based chemotherapy has improved survival rates among men with castration-sensitive prostate cancers, indicating its effectiveness in this patient population[2].

Market Analysis

Current Market Size and Growth

The global docetaxel market has been valued at USD 114.78 billion in 2023 and is projected to reach USD 252.46 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 9.70% during the forecast period (2024-2032)[2].

Market Segmentation

  • Geographical Segmentation: The market is segmented into Americas, Europe, Asia Pacific (APAC), and Middle East & Africa (MEA). North America is currently the largest market, while Europe is expected to be the fastest-growing region[2].

  • Cancer Type: Docetaxel is used in treating various cancers, including breast, prostate, stomach, and non-small cell lung cancers. The increasing incidence of these cancers is driving the demand for docetaxel[2].

Market Drivers

  • Increasing Cancer Incidence: The rising number of cancer cases globally is a significant driver for the docetaxel market. For instance, around 174,650 new cases of prostate cancer were diagnosed in the U.S. in 2019[2].

  • Advancements in Treatment: The approval of Taxotere in combination with other drugs for various cancer types, such as the TPF regimen for head and neck squamous cell carcinoma, has boosted its market growth[3].

Market Projections

Forecast Period

The global oncology drugs market, which includes docetaxel, is expected to grow significantly. Here are some key projections:

  • Oncology Drugs Market: The global oncology drugs market is valued at USD 231.56 billion in 2024 and is projected to reach USD 532.91 billion by 2031, growing at a CAGR of 12.6% during the forecast period (2024-2031)[5].

  • Docetaxel Market: Specifically, the docetaxel market is expected to reach USD 252.46 billion by 2032, driven by the increasing prevalence of cancers and the adoption of targeted therapies[2].

Market Trends

  • Shift to Targeted Therapies: While cytotoxic drugs, including docetaxel, currently hold a dominant position, the market is expected to shift towards targeted therapies and immunotherapies due to their higher efficacy and reduced side effects[5].

  • Geographical Growth: Europe is anticipated to be the fastest-growing region for the docetaxel market, driven by advancements in healthcare infrastructure and increasing cancer incidence[2].

Key Takeaways

  • Clinical Trials: Ongoing and completed trials have demonstrated the efficacy of Taxotere in various cancer types, including non-small cell lung cancer, prostate cancer, and head and neck squamous cell carcinoma.

  • Market Growth: The global docetaxel market is projected to grow significantly, driven by increasing cancer incidence and advancements in treatment options.

  • Market Segmentation: The market is segmented geographically and by cancer type, with North America being the largest market and Europe expected to be the fastest-growing region.

  • Market Drivers: The increasing incidence of cancers and advancements in treatment options are key drivers for the docetaxel market.

FAQs

What is Taxotere used for?

Taxotere, or docetaxel, is used in the treatment of various types of cancer, including breast, prostate, stomach, and non-small cell lung cancers.

What are the key findings from clinical trials involving Taxotere?

Clinical trials have shown that Taxotere, especially in combination with other drugs like cisplatin and 5-FU, improves survival rates and progression-free survival in patients with head and neck squamous cell carcinoma and prostate cancer.

How large is the global docetaxel market?

The global docetaxel market was valued at USD 114.78 billion in 2023 and is projected to reach USD 252.46 billion by 2032.

What are the main drivers of the docetaxel market growth?

The main drivers include the increasing incidence of cancers globally and advancements in treatment options, such as the approval of combination therapies.

Which region is expected to be the fastest-growing for the docetaxel market?

Europe is anticipated to be the fastest-growing region for the docetaxel market.

What is the projected CAGR for the global oncology drugs market?

The global oncology drugs market is expected to grow at a CAGR of 12.6% during the forecast period (2024-2031).

Sources

  1. AstraZeneca Clinical Trials: "An open randomised non comparative phase II trial of docetaxel (taxotere) in combination with ZD1839 (Iressa) and docetaxel alone as second line chemotherapy in patients with advanced or metastatic non small cell lung cancer."
  2. Straits Research: "Docetaxel Market Size, Share & Analysis 2032."
  3. BioSpace: "Head and Neck Squamous Cell Carcinoma Market Estimated to Reach USD 2.4 Billion by 2034."
  4. National Cancer Institute: "Clinical Trials Using Docetaxel."
  5. Coherent Market Insights: "Oncology Drugs Market to Reach USD 532.91 Billion by 2031."

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.