Last reviewed · How we verify
NCT05636644
Neoadjuvant Effect of Albumin Binding Paclitaxel Compared With Common Paclitaxel in Breast Cancer：an Observational Single Center Study of Clinical Efficacy in Adjuvant Chemotherapy
trial testing Taxol in Breast Cancer in 112 participants. Status unknown.
1 February 2025
Quick facts
| Lead sponsor | Mei Zhang |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 112 |
| Start date | 4 November 2022 |
| Primary completion | 1 February 2025 |
| Estimated completion | 16 June 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Taxol (Nabpaclitaxel) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Mei Zhang
Who can join
Adults 20 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In recent years, the incidence rate of breast cancer has remained high. In China, breast cancer is the malignant tumor with the highest incidence rate among women. Although the research and development of various targeted drugs and the improvement of clinical treatment system have effectively improved the 5-year survival rate of breast cancer patients in China, the clinical treatment effect of breast cancer is still unsatisfactory. It is speculated that the main reasons for the poor clinical efficacy of breast cancer are drug tolerance, recurrence, distant metastasis, etc., which further leads to some limitations in the exploration of clinical drug development and regulatory mechanism. Paclitaxels are common chemotherapeutic drugs, which have been widely used in the treatment of breast cancer, ovarian cancer and some lung cancer. In2005, albumin binding paclitaxel was approved by FDA for the treatment of breast cancer patients. It is highly hydrophobic and requires a mixture of polyethylene castor oil and ethanol. These solvents will increase the toxic reactions of patients treated with paclitaxel, including severe allergic and anaphylactic reactions, and irreversible peripheral neuropathy, usually requiring the use of corticosteroids and antihistamines in advance.In order to further confirm the advantages of albumin binding paclitaxel and common paclitaxel chemotherapeutic drugs in neoadjuvant chemotherapy of breast cancer, this project intends to explore albumin binding based on different molecular types of breast cancer (luminal a, B, HER2 +, triple negative) An observational study on the efficacy of neoadjuvant chemotherapy with a-paclitaxel and common paclitaxel chemotherapeutic drugs. Randomized grouping confirmed the effectiveness of albumin binding paclitaxel replacing common paclitaxel in neoadjuvant chemotherapy of breast cancer with different molecular types, providing evidence-based medical evidence for the selection of paclitaxel chemotherapeutic drugs based on breast cancer molecular types. At the same time, the patients with poor efficacy among the patients who selected the neoadjuvant chemotherapy scheme for breast cancer according to the guidelines of NCCN and CSCO were screened for clinical transformation research (including basic experimental research, follow-up intensive treatment selection, and providing basis for entering other drug clinical trials). For the patients who achieved the clinical efficacy of PCR with neoadjuvant chemotherapy, we further analyzed the reasons to explore a better scheme of neoadjuvant chemotherapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05636644
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Taxol
Trials testing the same drug.
- NCT06839105 — A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies · Phase 1 · recruiting
- NCT04238988 — Carboplatin-Paclitaxel-Pembrolizumab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer · Phase 2 · unknown
- NCT01952249 — A Study of Demcizumab Plus Paclitaxel in Subjects With Platinum Resistant Ovarian · Phase 1 · terminated
- NCT00394251 — Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adju · Phase 2 · completed
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Mei Zhang trials
Trials by the same sponsor.
- NCT06187818 — Follow up Study of Crocin on Cardiac Function Protection in Patients With Breast Cancer Undergoing Neoadjuvant Chemother · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05636644 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mei Zhang
- Last refreshed: 5 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05636644.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing