Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles

Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles

Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles

Paclitaxel+Carboplatin

Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles

Makoto Yasuda, M.D.

The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

This is a randomized, multicenter study. Patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage II vs III vs IV, and histology (clear cell or mucinous vs. serous or others). Patients are randomized to one of two treatment arms.

Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

Arm II: Patients receive paclitaxel IV over 1 hour days 1, 8, and 15 and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

In both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. Additional 3 cycles are given if clinical partial or complete response after 6 cycles.

PROJECTED ACCRUAL: A total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. Assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.

Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma

Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma

From the registration date, the earliest observed event from any of the following events 1. Death from any cause death date 2. The date of the first diagnostic imaging examination that confirmed exacerbation and recurrence.

Clinical exacerbation diagnosis date if not based on diagnostic imaging 3. If none of the above events are observed, the most recent outpatient consultation date / in hospital

The period from the registration date to the date of death due to any cause. In the case of survivors, the final surviving confirmation date will be censored.

In the case of untraceable cases, the last surviving confirmation date before tracking becomes impossible will be censored.

Adverse Event assessed by CTC(Version 2.0 Japanese version)

Japanese Gynecologic Oncology Group

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

749 patients will be assigned into nab-Paclitaxel group.

749 patients will be assigned into paclitaxel group

Nab-P (Abraxis BioScience, LLC., Mclrose Park, IL, USA; drug license No. H20091059), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; drug license No. Guoji Zhunzi H20020181), AUC=2 mg•min/mL, intravenous drip for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.

nab-Paclitaxel+carboplatin

Paclitaxel (Yangtze River Pharmaceutical Co., Ltd., Taizhou, Jiangsu Province, China; drug license No. Guoyao Zhunzi H20053001), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin, AUC=2 mg•min/mL, intravenous infusion for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.

Paclitaxel+carboplatin

Xi Gu, M.D.

Caigang Liu

Caigang Liu, M.D., Ph.D.

Triple-negative breast cancer (TNBC) accounts for about 20% of clinical breast cancer. Clinical characteristics include early onset, high malignancy and heterogeneity. There is no effective drug target for TNBC, resulting in poor outcomes, high relapse rate and distant metastasis. So, further research on TNBC pathological features is particularly important.

Compared with the solvent-based paclitaxel, albumin-bound paclitaxel (nab-P) demonstrates a stronger therapeutic effect. With albumin nanoparticles as a carrier, nab-P increases the concentration of extra-tumor drugs by passing through the albumin receptor (Gp60) transmembrane pathway and the secreted protein acidic and rich in cysteine (SPARC) approach that binds to the extracellular matrix of the tumor. Numerous clinical trials have found that nab-P is superior to the solvent-based paclitaxel in the treatment of breast cancer, especially in breast cancer with poor prognosis. However, the current efficacy of nab-P in the treatment of TNBC has not been fully verified. The mechanism underlying the killing effect of nab-P on TNBC breast cancer cells remains unclear yet. This trial will compare the therapeutic effect of nab-P with solvent-based paclitaxel in TNBC patients, and seek for important scientific clues, scientific evidence, and clinical data for nab-P in the treatment of TNBC.

Breast cancer has been one of the most common malignant tumors with highest morbidity and mortality that threatens women's health worldwide. Among US women, there were 250,000 new invasive breast cancers and 40,000 breast cancer deaths in 2017. In the US, 12.4% women develop breast cancer in their lifetime, and the incidence of breast cancer in women over 50 years of age has increased significantly. Although the development of molecular typing and comprehensive treatments have significantly improved the prognosis of breast cancer patients, the recurrence and metastasis of breast cancer is still the main cause of death in breast cancer patients.

TNBC accounts for about 20% of clinical breast cancer. Clinical characteristics include early onset, high malignancy and heterogeneity. There is no effective drug target for TNBC, resulting in poor outcomes, high relapse rate and distant metastasis. So, further research on TNBC pathological features is particularly important.

Paclitaxel is a natural secondary metabolite isolated and purified from the bark of Taxus chinensis. It has been clinically proven to have a good anti-tumor effect. However, polyoxyethylene castor oil/ethanol is often used as a solvent for paclitaxel in clinical practice, and this solvent-based paclitaxel is prone to causing severe allergic reactions, even aggravating myelosuppression and neurotoxicity. In addition, the solvent-based paclitaxel can also influence the efficacy of other drugs by inhibiting albumin-mediated drug delivery. nab-P is a novel paclitaxel that can compensate for the adverse effects of solvent-based paclitaxel and have good efficacy and safety. Compared with the solvent-based paclitaxel, nab-P demonstrates a stronger therapeutic effect. With albumin nanoparticles as a carrier, nab-P increases the concentration of extra-tumor drugs by passing through the albumin receptor (Gp60) transmembrane pathway and the secreted protein acidic and rich in cysteine (SPARC) approach that binds to the extracellular matrix of the tumor. Numerous clinical trials have found that nab-P is superior to the solvent-based paclitaxel in the treatment of breast cancer, especially in breast cancer with poor prognosis. However, the current efficacy of nab-P in the treatment of TNBC has not been fully verified. The mechanism underlying the killing effect of nab-P on TNBC breast cancer cells remains unclear yet.

This trial will compare the therapeutic effect of nab-P with solvent-based paclitaxel in TNBC patients, and seek for important scientific clues, scientific evidence, and clinical data for nab-P in the treatment of TNBC.

Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT

Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective Randomized Controlled Clinical Trial

Pathologic complete remission refers to no invasive tumor cell remnants in the pathological examination of the primary mammary gland and axillary lymph nodes surgically removed. The PCR indicates the proportion of the patients with pathological complete remission to the total number of patients.

The CD44/CD24 expression in the breast tissues will be detected by immunohistochemistry before treatment and at 9 and 18 weeks of treatment, to determine the proportion of tumor stem cells in the lesion.

PFS refers to the time from random enrollment to disease progression or death for any reason indicated by imaging findings. PFS will be recorded within 5 years of follow-up.

OS refers to the time from enrollment to death

Any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma	NCT00226915	Epithelial Ovar... Primary Periton... Fallopian Tube ...	Paclitaxel+Carb... Paclitaxel+Carb...	20 Years -	Japanese Gynecologic Oncology Group
Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT	NCT04137653	Breast Cancer	nab-Paclitaxel+... Paclitaxel+carb...	18 Years - 70 Years	Shengjing Hospital

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