CClinicalTrials.gg
Status unknownNCT04194684Updated Dec 11, 2019

Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer

A Phase 2 interventional study of nab-paclitaxel in Breast Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
108
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。

02

Conditions studied

  • Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 108 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Female, 18 to 70 years old;
  2. histologically confirmed recurrent or metastatic breast cancer, ER-positive (> 10%), HER-2 negative (Definition: immunohistochemical [IHC] 0, 1+, or in situ hybridization [ISH] negative It is defined as the ratio of HER2 gene copy number to the number of CEP17 signals is less than 2.0, or for single probe detection, the HER2 gene copy number is less than 6);
  3. After transfer, ≤2 lines and ≥1 line endocrine therapy, and progress;
  4. at least one measurable lesion according to RECIST 1.1 ;
  5. ECOG score≤2;
  6. Expected survival≥3 months;
  7. Bone marrow function: white blood cells≥3×109/L, neutrophils≥1.5×109/L, platelets ≥100×109 / L, hemoglobin≥90g / L;
  8. Liver and kidney function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (Cr) ≤1.5 times the upper limit of normal value;
  9. taxane adjuvant chemotherapy for more than 1 year;
  10. Women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose
  11. Sign written informed consent before the test.

Exclusion criteria

Exclusion Criteria:

  1. Received chemotherapy after transfer;
  2. Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;
  3. Uncontrolled brain metastases;
  4. Severe systemic infections;
  5. Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;
  6. Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;
  7. History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
  8. Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;
  9. Patients participating in other clinical trials at the same time;
  10. Any medical condition in which the investigator considers the patient unsuitable for study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Assigned Interventions

    Nab-paclitaxel

    Drug: nab-paclitaxel

Interventions

  • Drugnab-paclitaxel

    nab-paclitaxel 125mg / m2, intravenous drip 30min, d1, 8, 21 days as a cycle, until the disease progresses or intolerable toxicity. According to the calculation results, the administered dose can be within ± 10% of the calculated dose.

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.

    Time frame: Estimated up to 1 year

Secondary outcomes

  1. Clinical benefit rate

    Defined as proportion of complete response 、partial response and stable disease according to RECIST 1.1 criteria.

    Time frame: CR+PR+SD≥8 weeks

  2. Progression-Free Survival (PFS)

    Calculated from the time the study drug was first administered to the first confirmation of disease progression or death (whichever occurs first)

    Time frame: Estimated up to 2 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04194684
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Peng Yuan (Professor, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Dec 11, 2019
Start date
Dec 28, 2019 (estimated)
Primary completion
Dec 28, 2022 (estimated)
Completion
Jan 30, 2023 (estimated)
Last update
Dec 11, 2019

Study contacts

Peng Yuan
Contact
yuanpeng01@hotmail.com
+8613501270834
Peng Yuan
study chair · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion