Status unknownNCT03919253Updated Apr 18, 2019

Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study

A Phase 2 interventional study of pyrotinib maleate tablets+nab-paclitaxel in HER2-positive Breast Cancer, sponsored by Hebei Medical University Fourth Hospital. Status unknown. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by Hebei Medical University Fourth Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 80
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: Female

Study summary

This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced breast cancer.

Conditions studied

HER2-positive Breast Cancer

In context

Lead sponsor

Hebei Medical University Fourth Hospital is the lead sponsor of 81 studies on the registry; 55 are open to participants now.

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

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1. Age: 18-70 years old，female; 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3. Imaging examination confirmed recurrent/metastatic breast cancer； 4. Patients must have previous treatment with trastuzumab more than 9 weeks; 5. Untreated for metastatic/metastatic disease (except for endocrinotherapy); 6. Patients with at least one measurable lesions by RECIST version 1.1； 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2； 8. Life expectancy greater than or equal to 3 months; 9. Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2*ULN, but ≤5*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50% 10. Doctors believe that treatment can bring benefits to patients； 11. Participants were willing to join in this study, and written informed consent.

Exclusion criteria

Exclusion Criteria:

1. A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction); 2. Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. History of psychiatric drugs abuse or patients with mental disorders; 4. Pregnant or lactating women; 5. Less than 4 weeks from the last clinical trial 6. The researchers think inappropriate.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 80 participants (estimated)

Study arms

Experimental
pyrotinib maleate tablets+nab-paclitaxel
pyrotinib maleate tablets: 400mg orally once daily continunously; nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.
Combination Product: pyrotinib maleate tablets+nab-paclitaxel

Interventions

Combination productpyrotinib maleate tablets+nab-paclitaxel
Drug pages: Shr-1258 dimaleate · Albumin-Bound Paclitaxel
pyrotinib maleate tablets: 400mg orally once daily continunously nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.

What researchers measure

Primary outcomes

Progress-free survival(PFS)
Baseline to measured date of progress or death from any cause
Time frame: three years

Secondary outcomes

Objective response rate (ORR)
Baseline to measured stable disease
Time frame: three years
Clinical Benefit Rate (CBR)
The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks
Time frame: three years
Disease control rate(DCR)
Rate of the patients with disease control
Time frame: three years
Overall survival (OS)
Baseline to measured date of death from any cause
Time frame: up to death
Safety (number of Participants with adverse events)
Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The number of Participants with adverse events will be recorded at each treatment visit.
Time frame: three years

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2019; primary completion for Apr 2020, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 15, 2019
First posted: Apr 18, 2019
StartEst.: Apr 30, 2019
Primary completionEst.: Apr 30, 2020
CompletionEst.: Apr 30, 2022
Last update: Apr 18, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03919253
Lead sponsor: Hebei Medical University Fourth Hospital
Responsible party: Sponsor
First posted: Apr 18, 2019
Start date: Apr 30, 2019 (estimated)
Primary completion: Apr 30, 2020 (estimated)
Completion: Apr 30, 2022 (estimated)
Last update: Apr 18, 2019

Oversight

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 Apr 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.

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.

Studies of the drugs tested here: Shr-1258 dimaleate · Albumin-Bound Paclitaxel

Other studies from this sponsor

Hebei Medical University Fourth Hospital

Start the discussion