Breast CancerNCT01732939
Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer
An observational study of Breast Cancer, run by Hospital Affiliated to Military Medical Science, Beijing at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2012to May 2014
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: diaganosis of invasive breast cancer, tumor size > 2.0cm by MRI or ultrasound or clinical examination.
Who may be able to join
- 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%
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- Lab test :
- Absolute neutrophil count > 1,500/mm3
- Total Bilirubin ≤ 2×ULN
- AST and ALT ≤ 2.5×ULN
- serum creatinine ≤ 1.5×ULN
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital affiliated academy military medical science
Beijing, Beijing Municipality, 100071
Tao Wang, MD, 8610-66947430
Shaohua ZHANG, MD, 8610-66947173
About this study
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
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response rate
Measured: one year
Secondary outcomes (1)
clinical response rate, safety
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Affiliated to Military Medical Science, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zefei Jiang, MD, Principal investigator, Hospital Affiliated Military Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732939
- Sponsor's protocol ID
- 307BCNeo-01
- Status last verified
- Feb 2014
- First submitted
- 10 Oct 2012
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer
- ClinicalTrials.gov ID
- NCT01732939
- Acronym / sponsor ID
- 307BCNeo-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Affiliated to Military Medical Science, BeijingUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diaganosis of invasive breast cancer, tumor size > 2.0cm by MRI or ultrasound or clinical examination.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pathological complete response rate
Time frame: one year
1 secondary outcome
clinical response rate, safety
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zefei Jiang, MD principal investigator
Hospital Affiliated Military Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hospital Affiliated to Military Medical Science, Beijing at 1 site 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 11 inclusion and 6 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2014.