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Metastatic Breast Cancer (MBC)Phase 3NCT06143553

Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer

A Phase 3 study testing Paclitaxel Polymeric Micelles for Injection, Eribulin Mesilate injection and Capecitabine Tablets in people with Metastatic Breast Cancer (MBC), run by Shanghai Yizhong Pharmaceutical Co., Ltd. at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer (MBC)
What is being tested?
Paclitaxel Polymeric Micelles for Injection, Eribulin Mesilate injection and Capecitabine Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
3 sitesChina
Study dates
25 Sep 2023to Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible subjects must meet all the following criteria:
  • Male or female 18 years and older;
  • Understand the purpose, benefits and risks of this clinical trial, voluntarily participate in and sign the written informed consent;
  • The Eastern Cooperative Oncology Group (ECOG)performance status is 0 or 1;
  • Histologically or cytologically confirmed (local laboratory) HER2-metastatic breast cancer from recently acquired or newly acquired tumor biopsies from locally-relapsed or metastatic sites (HER2- is defined as a standard immunohistochemical (IHC) test result of 0 or 1+; Or the IHC test result is 2+ and the ISH test result is negative including FISH/CISH/SISH)；
  • Archival slides or newly obtained biopsy slides from metastatic or recurrent sites are available (Note: Bone lesion biopsy is not accepted);
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  • Subjects who are refractory or relapsed after ≥2 and ≤4 prior systemic chemotherapy regimens or antibody-drug conjugates (ADC) for MBC are eligible(Subjects were eligible for inclusion if their previous chemotherapy regimen included taxanes or not; Subjects using taxanes for adjuvant or neoadjuvant chemotherapy more than 6 months after the treatment, and Subjects using taxanes for advanced-stage treatment more than 3 months after the treatment, with recurrence or metastasis are eligible.) Adjuvant or neoadjuvant chemotherapy for early-stage disease can be considered as one of the required prior chemotherapy regimens if unresectable, locally advanced, or metastatic disease develops within 12 months after completion of the regimen.( Note: Therapies for bone metastases (e.g., bisphosphonates, denosumab, etc.) are not considered prior systemic chemotherapy for advanced disease.)；
  • Subjects are eligible to receive one the chemotherapy regimens in the TPC group；
  • According to RECIST 1.1, subjects with measurable lesions on contrast-enhanced CT or MRI (≥10mm in the major dimension on CT or MRI scan, and ≥15mm in the minor dimension of lymph nodes); Subjects with unmeasurable skeletal lesions only are not accepted；
  • Functions of major organs such as heart, lung, liver and kidney are basically normal；
  • Blood routine examination meets the following criteria (No blood transfusions, blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors were used within 7 days before the blood routine test)：
  • : White blood cell count ≥3.0x109/L; Neutrophil count ≥1.5x109/L；
  • : Platelet count ≥100×109/L;
  • ：Hemoglobin≥90g/L;
  • : If subjects receive blood component transfusion (red blood cells, platelets, etc.) during the screening period, blood routine test should be performed again at an interval of 1 week to meet the above criteria before continuing screening.
  • Blood biochemical examination must meet the following criteria:
  • : Total bilirubin ≤1.5 times the upper limit of normal (ULN);
  • : Aspartate Transaminase（AST）, Alanine Aminotransferase（ALT）, or Alkaline phosphatase（ALP）≤2.5 times ULN (ALT, AST, or ALP≤ 5×ULN for subjects with liver metastases, and ALP≤10×ULN for subjects with bone metastases);
  • : Creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 ml/min.
  • Subjects have no symptoms of cardiac dysfunction (NYHA class ≤II) at baseline and no significant or clinically insignificant ECG abnormalities;
  • Subjects have good compliance and voluntarily comply with the clinical trial protocol during the study, followed up by the investigators;
  • All women of childbearing age, men of childbearing potential, or their spouses who have no plans to have children or donate sperm during the entire trial period and up to 6 months after the last dose of medication, or who voluntarily used effective contraception; Women of childbearing age who have a negative blood/urine pregnancy test within 7 days prior to enrollment.

Who cannot join

  • Subjects meet the following criteria are not eligible for inclusion:
  • Known allergy or intolerance to either study treatment or any excipients；
  • Previous use of antibody-drug conjugate (ADC) with anti-microtubule inhibitor as payload drug are not eligible;
  • Primary brain tumors or central nervous system metastases (including leptomeningeal metastases), except for single brain metastases strictly controlled asymptomatic subjects; Subjects with intracranial hypertension or neuropsychiatric symptoms after treatment of central nervous system tumors;
  • Subjects with acute or chronic infections that have not been eliminated, or subjects with other serious diseases at the same time;
  • Subjects have other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
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  • Subjects with a known history of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory disease within 6 months before enrollment;
  • Subjects with active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), clinically significant gastrointestinal (GI) bleeding, intestinal obstruction, or GI perforation within 6 months before enrollment;
  • Subjects with active hepatitis, or liver metastasis is more than 3/4 of the whole liver;
  • Subjects with third-space effusions (e.g., moderate-to-massive pleural effusion, moderate-to-massive pericardial effusion, ascites) that cannot be controlled by drainage or other means; Subjects with a small amount of pleural effusion without clinical symptoms and no need for clinical intervention should be strictly controlled before enrollment;
  • Subjects with mental illness or disorder, poor compliance, or inability to cooperate, or describe treatment responses;
  • Subjects who cannot tolerate chemotherapy due to severe organic disease or major organ failure, such as decompensated heart and lung failure;
  • Subjects with bleeding disorders;
  • Subjects with organ transplant;
  • Subjects with bad drug addicts, long-term alcoholics, infectious diseases such as AIDS;
  • Subjects on long-term use of adrenocortical hormones or immunosuppressants;
  • Subjects who received vaccines (including live and live attenuated vaccines) such as measles, mumps, rubella, varicella, yellow fever, rabies, Bacille Calmette-Guérin vaccine（BCG ）and typhoid (oral) vaccines within 4 weeks before enrollment, or are scheduled to receive vaccines during the study period; Subjects who received all types of COVID-19 vaccines within two weeks before enrollment;
  • Subjects who received antineoplastic drugs (including but not limited to chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy, surgery (except diagnostic biopsy), etc.) within 2 weeks before enrollment or who still have grade ≥2 toxicity from previous antineoplastic therapy (except alopecia and grade ≤2 neurotoxicity caused by platinum) at enrollment;
  • Subjects with active hepatitis B or C (previous history of hepatitis B infection, with or without drug control, HBV DNA≥1×104 copies or ≥2000 IU/mL; Hepatitis C infection, HCV RNA≥15IU/mL); Or HIV antibody positive (testing is not necessary if there is no clinical evidence to suggest possible HIV infection);
  • Subjects are considered not able to complete the trial or otherwise unfit to participate in the study by the investigators.

Trial locations and contacts

3 sites in 1 country.

Xiaoya Wang contact

15601735965

15601735965@163.com

China3 sites, 3 recruiting

  • Jiangsu province Hospital

    Nanjing, Jiangsu, 210029

    Yongmei Yin, 13951842727, ym.yin@hotmail.com

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

    Jiong Wu

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

    Jian Zhang

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Controlled Phase Ⅲ Study of Paclitaxel Polymeric Micelles for Injection Versus Physician's Choice(TPC) in Human Epidermal Growth Factor Receptor 2-negative (HER2-) Metastatic Breast Cancer (MBC) Subjects Who Have Failed at Least Two Previous Chemotherapy Regimens.

This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens.

Treatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physician's Choice (TPC) group by the proportion of 1:1. Randomization is stratified according to three factors: number of lines of previous treatment for metastatic disease (2 or 3/4 lines), receptor status (triple-negative, non-triple-negative), and visceral metastasis (yes/no).

Read more

Progression-free survival (PFS) is the main efficacy indicator in this study. Treatment Group: Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.

Control Group: Physician's Choice Group, subjects are given Eribulin Mesilate injection; or capecitabine tablets; or gemcitabine hydrochloride for injection; or vinorelbine tartrate injection; or paclitaxel (albumin-bound). Three or four weeks constitutes one cycle of treatment.

If subject does not develop disease progression after 6 cycles of dosing, the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.

Superiority design is used in this study, progression-free survival (PFS) is the main efficacy indicator. Assuming α = 0.0249(unilateral, adjusted test level), power=80%, the median PFS of the treatment group is 6.0 months, the median PFS of the control group is 3.7 months, the enrollment period is 12 months, and the study period is 24 months. Using PASS (version 11.0) for calculation, a total of 152 subjects (76 in each group) are required to meet the statistical significance between the treatment group and the control group. In consideration of case expulsion, enlarged by 10%, a total of 168 subjects (84 in each group) are required.

Being tested
Paclitaxel Polymeric Micelles for Injection, Eribulin Mesilate injection, Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection
Keywords
Paclitaxel Polymeric Micelles for Injection, Metastatic Breast Cancer (MBC), human epidermal growth factor receptor 2-negative (HER2-)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel Polymeric Micelles for InjectionDrug

    Subjects are given 300 mg/m2 of Paclitaxel Polymeric Micelles for Injection without special infusion device,intravenously administrated for ≥ 3 hours.Three weeks constituted one course of treatment.

  • Eribulin Mesilate injectionDrug

    Subjects are given 1.4 mg/m2 of Eribulin Mesilate injection on days 1 and 8 of the 21-day cycle.

  • Capecitabine TabletsDrug

    Subjects are given 1000-1250mg/m2 of Capecitabine Tablets on days 1 to 14 of the 21-day cycle ,and twice a day (once in the morning and once in the evening; Total daily dose 2000-2500mg/m2).

  • Gemcitabine Hydrochloride for InjectionDrug

    Subjects are given 800-1200mg/m2 of Gemcitabine Hydrochloride for Injection on days 1, 8 and 15 of the 28-day cycle.

  • Vinorelbine Tartrate InjectionDrug

    Subjects are given 25mg/m2 of Vinorelbine Tartrate Injection every first day of the week.

  • Paclitaxel (albumin-bound)Drug

    Subjects are given 260mg/m2 of Paclitaxel (albumin-bound) on day 1 of the 21-day cycle,intravenous administration for more than 30 minutes.

Study groups in NCT06143553
Study groupRoleWhat they receive
Paclitaxel Polymeric Micelles for InjectionExperimental300mg/m2 of Paclitaxel Polymeric Micelles for Injection is intravenously administrated for ≥ 3 hours without special infusion device. The frequency of administration is once every 3 weeks (Q3W), and 3 weeks constitutes a treatment cycle.
Receives: Drug: Paclitaxel Polymeric Micelles for Injection
The Doctor chooses the treatment（TPC）Active comparatorControl Group：The Doctor chooses the treatment（TPC）：Eribulin Mesilate injection；Capecitabine Tablets；Gemcitabine Hydrochloride for Injection；Vinorelbine Tartrate Injection；Paclitaxel (albumin-bound). Eribulin Mesilate injection：on days 1 and 8 of the 21-day cycle, 1.4 mg/m2 , intravenous administration; Capecitabine Tablets: On days 1 to 14 of the 21-day cycle, 1000-1250mg/m2，oral administration, twice a day (once in the morning and once in the evening; Total daily dose 2000-2500mg/m2); Gemcitabine Hydrochloride for Injection: On days 1, 8 and 15 of the 28-day cycle, 800-1200mg/m2, intravenous administration; Vinorelbine Tartrate Injection: Every first day of the week, 25mg/m2，intravenous administration; Paclitaxel (albumin-bound): On day 1 of the 21-day cycle, 260mg/m2，intravenous administration for more than 30 minutes. Three weeks constituted one course of treatment.
Receives: Drug: Eribulin Mesilate injection; Drug: Capecitabine Tablets; Drug: Gemcitabine Hydrochloride for Injection; Drug: Vinorelbine Tartrate Injection; Drug: Paclitaxel (albumin-bound)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free-Survival

    PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first

    Measured: Randomization to measured PD or date of death from any cause（up to 24 months)

Secondary outcomes (4)

  1. Objective response rate

    Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Measured: Baseline to measured PD（up to 24 months)

  2. Overall survival

    Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow#up) were censored on the last date the participant was known to be alive.

    Measured: Randomization to date of death from any cause（up to 24 months)

  3. Disease Control Rate

    Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)

    Measured: Baseline to measured PD（up to 24 months)

  4. Incidence of adverse events

    Safety Endpoint

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start25 Sep 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06143553
Sponsor's protocol ID
SHYZ-ZSCJS-RXⅢ-01
Status last verified
Aug 2024
First submitted
16 Nov 2023
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel Polymeric Micelles for Injection, Eribulin Mesilate injection and Capecitabine Tablets in people with Metastatic Breast Cancer (MBC), run by Shanghai Yizhong Pharmaceutical Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaoya Wang (15601735965, 15601735965@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free-Survival (time frame: Randomization to measured PD or date of death from any cause（up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06143553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.

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