Status unknownNCT01732939Updated Feb 19, 2014

Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

An observational study in Breast Cancer, sponsored by Hospital Affiliated to Military Medical Science, Beijing. Status unknown at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Hospital Affiliated to Military Medical Science, Beijing · Observational

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 60
Ages: 18 Years and older
Sex: Female

Study summary

The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.

Read the detailed description

The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 60 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

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Lead sponsor

Hospital Affiliated to Military Medical Science, Beijing is the lead sponsor of 3 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

diaganosis of invasive breast cancer, tumor size > 2.0cm by MRI or ultrasound or clinical examination.

Inclusion criteria

Diagnosis of invasive ductal or lobular breast cancer.
Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)
Performance Status ECOG \<2
Age > 18 years
Tumor > 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky >50%
Lab test :
- Absolute neutrophil count > 1,500/mm3
  - Total Bilirubin ≤ 2×ULN
  - AST and ALT ≤ 2.5×ULN
- serum creatinine ≤ 1.5×ULN

Exclusion criteria

Exclusion Criteria:

Pregnant or breast feeding patients are excluded
stage Ⅳ breast cancer
History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin
uncontrolled cardiac disease
Active infection or chronic infection requiring chronic suppressive antibiotics
History of hypersensitivity reaction to investigating drugs

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 60 participants (estimated)

Groups and cohorts

AT
Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles
AT-NP
docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles

What researchers measure

Primary outcomes

pathological complete response rate
Time frame: one year

Secondary outcomes

clinical response rate, safety
Time frame: one year

Study locations

1 of 1 sites recruiting

Hospital affiliated academy military medical science
Beijing, Beijing 100071, China
- Tao Wang, MD · Contact · 8610-66947430
- Shaohua ZHANG, MD · Contact · 8610-66947173
- Zefei Jiang, MD · Principal investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01732939
Lead sponsor: Hospital Affiliated to Military Medical Science, Beijing
Responsible party: Sponsor
First posted: Nov 26, 2012
Start date: May 2012
Primary completion: Dec 2013
Completion: May 2014 (estimated)
Last update: Feb 19, 2014

Study contacts

Zefei Jiang, MD

principal investigator · Hospital Affiliated Military Medical Science

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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