CLINICAL TRIALS PROFILE FOR DOCETAXEL

505(b)(2) Clinical Trials for DOCETAXEL

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	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	University of Arizona	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
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	NCT00356122 ↗	Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)	Completed	Genentech, Inc.	Phase 2	2006-07-01	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.
New Combination	NCT00356122 ↗	Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)	Completed	Sanofi	Phase 2	2006-07-01	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.
New Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	Celgene Corporation	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.

All Clinical Trials for DOCETAXEL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002544 ↗	Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer	Completed	Arbeitsgemeinschaft fur Internistische Onkologie	Phase 3	1993-05-01	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 mitoxantrone is more effective with or without docetaxel. PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.
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.
NCT00002866 ↗	Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer	Completed	NCIC Clinical Trials Group	Phase 1	1996-08-12	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person 's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and epirubicin with and without G-CSF in treating women with metastatic breast cancer.

Clinical Trial Conditions for DOCETAXEL

Condition Name

Condition Name for DOCETAXEL
Intervention	Trials
Breast Cancer	405
Prostate Cancer	271
Non-small Cell Lung Cancer	147
Lung Cancer	114

Condition MeSH

Condition MeSH for DOCETAXEL
Intervention	Trials
Breast Neoplasms	597
Carcinoma, Non-Small-Cell Lung	535
Prostatic Neoplasms	508
Lung Neoplasms	467

Clinical Trial Locations for DOCETAXEL

Trials by Country

Trials by Country for DOCETAXEL
Location	Trials
Israel	94
Switzerland	93
India	91
Denmark	83
Sweden	81

Trials by US State

Trials by US State for DOCETAXEL
Location	Trials
California	421
Texas	402
New York	393
Florida	340
Ohio	322

Clinical Trial Progress for DOCETAXEL

Clinical Trial Phase

Clinical Trial Phase for DOCETAXEL
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	61
PHASE2	91

Clinical Trial Status

Clinical Trial Status for DOCETAXEL
Clinical Trial Phase	Trials
Completed	1182
Recruiting	449
Terminated	298

Clinical Trial Sponsors for DOCETAXEL

Sponsor Name

Sponsor Name for DOCETAXEL
Sponsor	Trials
National Cancer Institute (NCI)	359
Sanofi	207
Hoffmann-La Roche	89

Sponsor Type

Sponsor Type for DOCETAXEL
Sponsor	Trials
Other	2702
Industry	1614
NIH	366

DOCETAXEL Market Analysis and Financial Projection

Last updated: April 27, 2026

Docetaxel Clinical Trials Update, Market Analysis, and Projection (2025-2035)

What is docetaxel and how is it positioned commercially?

Docetaxel is a taxane chemotherapeutic approved for multiple solid tumors. Commercially, it is a mature, widely used oncology product with:

• Established pricing pressure from generics and biosimilar-style competitive dynamics in oncology small molecules.
• Continued demand due to broad guideline coverage across breast, gastric/GEJ, lung, prostate, and other cancers.
• Ongoing formulation and line-extension innovation (notably co-formulations, dosing/administration improvements, and combination strategies) rather than broad new-molecule breakthroughs.

---

What is the current clinical trial landscape for docetaxel?

Docetaxel’s clinical activity in recent years has concentrated on:

• Combination regimens (with immune checkpoint inhibitors, targeted agents, anti-angiogenics, or other cytotoxics).
• Refinement in patient selection (biomarkers, earlier lines, metastatic versus locally advanced settings).
• New schedules and administration strategies intended to improve tolerability and real-world feasibility.

A practical way to track “where development money is going” is by separating: 1) Trials that test docetaxel + standard oncology backbones (often for regulatory label expansion or sequence optimization). 2) Trials that test docetaxel in biomarker-defined subgroups (primarily for response or survival endpoints).

Operational take: the docetaxel pipeline is not dominated by single-drug superiority claims. It is dominated by combination optimization, which keeps trial volume steady even as the drug’s standalone innovation cycle matures.

---

Which clinical trial categories are most active and why?

Key categories observed across oncology development programs using docetaxel include:

• Docetaxel + PD-1/PD-L1 inhibitors
  Goal: improve systemic response depth and convert durable response signals into survival improvements, typically in metastatic and first-line settings.

• Docetaxel + anti-angiogenesis agents
  Goal: improve vascular normalization and tumor drug delivery.

• Docetaxel + targeted agents
  Goal: leverage specific pathway dependencies (e.g., HER2 status in breast cancer, androgen receptor pathway modulation in prostate settings).

• Docetaxel in earlier lines with stratification
  Goal: reduce crossover bias and clarify benefit versus comparator standards.

These patterns are consistent with how mature cytotoxics are “kept alive” in development: docetaxel is used as a validated efficacy anchor in regimens that can show incremental benefits.

---

What do trial registries show for docetaxel activity?

Docetaxel trials remain indexed on public registries and are searchable through standard “docetaxel” terms. The two highest-signal sources for ongoing trials are:

• ClinicalTrials.gov (US/global program visibility)
• WHO ICTRP via partner registries

These sources provide the working set for counting active studies, mapping indications, and monitoring sponsor patterns (industry vs academic consortia).

Actionable method for diligence (market and R&D):

• Filter by “Recruiting,” “Active, not recruiting,” and “Not yet recruiting.”
• Stratify by indication and combination partner.
• Cross-check sponsors for repeat combinations that indicate likely phase progression.

---

Docetaxel Market Analysis

How big is the docetaxel market and what is driving demand?

Docetaxel demand is driven by:

• Broad tumor coverage (breast, gastric/GEJ, NSCLC, prostate, and others).
• Continued use in both adjuvant and metastatic protocols depending on label and regimen selection in each geography.
• Practical dosing schedules that translate into routine oncology practice.

Market behavior for mature oncology chemotherapy:

• Volume demand is stable-to-declining in mature segments as:
  • generics capture most of the market,
  • treatment paradigms shift to immunotherapy and targeted therapy.
• Real revenue stabilizes in later years mainly through:
  • geography-by-geography pricing,
  • uptake in regimens where immunotherapy is combined with chemotherapy,
  • persistence of cytotoxic backbone use in first-line and salvage settings.

---

What is the competitive landscape (brand vs generic) for docetaxel?

Docetaxel faces intense competition typical of mature small-molecule oncology drugs:

• Original branded products competed initially through differentiation on administration convenience and clinical familiarity.
• Generics dominate most markets post-patent expiry, compressing price and strengthening payer pressure.
• Differentiation trends shift to:
  • manufacturing reliability and supply assurance,
  • formulation and handling improvements,
  • contracting and tender positioning in hospital procurement.

Implication for forecasting: market share is more sensitive to supply continuity and tender awards than to marginal clinical differentiation.

---

How should investors and R&D teams model docetaxel revenue durability?

Revenue durability depends on two levers:

1) Treatment protocol incidence

• How often docetaxel appears in guideline-backed regimens by geography and line of therapy. 2) Net price trajectory
• Driven by generics and procurement pressure.

A defensible projection model for docetaxel typically treats revenue growth as:

• mostly volume-limited,
• price-driven downward,
• occasional step-ups from regimen re-integration (for example, docetaxel remains part of combination frameworks that continue to be used in immunotherapy eras).

---

Projection (2025-2035)

What is the base-case market outlook?

Base-case assumption for projection direction:

• Moderate long-run volume stability as docetaxel continues as a backbone in multi-agent oncology protocols.
• Slow net price erosion in many markets due to generic competition.
• Periodic demand elasticity from combination regimens that keep chemotherapy in front-line care.

Net effect: low single-digit growth in revenue in nominal terms in many markets is more plausible than strong expansion, with variability driven by regional procurement and patent/legal events affecting generic supply.

---

What does a scenario-based projection look like?

Because docetaxel is mature, forecasts are best expressed as scenario bands tied to treatment protocol share and pricing.

Scenario bands (high-level)

• Bear case: faster procurement price compression and regimen substitution toward non-taxane options reduce net revenue.
• Base case: stable protocol incidence and continued use in combination regimens offset pricing pressure.
• Bull case: combination trial success supports expanded label usage or regimen positioning that increases protocol frequency, slowing price decline through demand stickiness and supply constraints.

---

Where could upside come from?

Upside is most likely from:

• New combination evidence that supports more frequent docetaxel integration.
• Preferential use in settings where chemotherapy remains the standard backbone while immunotherapy is added.
• Tender-level supply constraints that temporarily stabilize net price.

---

Where is downside most likely?

Downside is most likely from:

• Rapid adoption of non-taxane regimens where efficacy is comparable and tolerability is improved.
• Intensification of generic competition, increased tender frequency, and margin squeeze.
• Treatment-line shifts that reduce cytotoxic exposure duration.

---

Evidence and Reference Points (Regulatory, Labeling, and Trial Visibility)

What are the regulatory and informational anchors for diligence?

For document traceability and label-based verification, the key public reference points are:

• EMA product information pages for docetaxel-containing medicines
• FDA label repositories and prescribing information
• ClinicalTrials.gov and WHO ICTRP for trial status and sponsor mapping

These sources let teams validate:

• indication scope and label language,
• dosing regimens that drive protocol incidence,
• trial endpoints and line-of-therapy positioning used in commercial forecasting.

---

Key Takeaways

• Docetaxel is a mature oncology backbone with clinical development concentrated in combination regimens rather than standalone drug reinvention.
• Trial activity persists through PD-1/PD-L1, anti-angiogenesis, targeted therapy pairings, and biomarker-stratified studies.
• Market dynamics are defined by generic price pressure and tender-driven procurement, with revenue stability supported by broad guideline usage.
• Projections are best modeled with scenario bands driven by protocol incidence and net price trajectory from generics.

---

FAQs

1) Why does docetaxel still have active clinical trials despite being a mature drug?

Docetaxel is a validated efficacy anchor. Sponsors use it to build combination regimens with modern agents and to optimize sequencing and patient selection in current oncology treatment frameworks.

2) What trial categories most influence future commercial uptake for docetaxel?

Phase 2/3 studies that change line-of-therapy positioning, show survival benefit versus chemotherapy controls, or establish biomarker-defined subgroups with improved outcomes.

3) How do generics affect docetaxel market projections?

They drive net price erosion and shift competition to supply reliability and hospital contracting. Volume stability can keep revenue from collapsing, but growth tends to be limited without protocol expansion.

4) Where does docetaxel face the strongest treatment substitution risk?

Where non-taxane regimens demonstrate comparable efficacy with better tolerability, and where targeted or immunotherapy-driven protocols reduce chemotherapy exposure.

5) What is the most practical way to monitor docetaxel pipeline progress?

Track ClinicalTrials.gov and WHO ICTRP using “docetaxel” filters, then categorize by combination partner, recruiting phase, and indication with guideline relevance.

---

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] World Health Organization. International Clinical Trials Registry Platform (ICTRP). https://www.who.int/clinical-trials-registry-platform
[3] European Medicines Agency (EMA). Medicine information and product pages for docetaxel-containing medicines. https://www.ema.europa.eu/
[4] U.S. Food and Drug Administration (FDA). Drug approval and label information repositories. https://www.accessdata.fda.gov/