Human Epidermal Growth Factor 2 Negative Carcinoma of BreastNCT01779531
Compare the Outcomes of XT and XEC Adjuvant Chemotherapy in HER2-negative Luminal B Breast Cancer Patients
An observational study of Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Guangdong Academy of Medical Sciences at 1 site in China.
Trial summary
Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 2015
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HER2 negative Luminal B subtype breast cancer patients
Who may be able to join
- Chinese population surgery patients with invasive breast cancer；
- Stage II-III；
- ER positive；
- HER2 negative；
- Ki67≥14%；
- Aged between 18 and 70 years old；
- The maximum diameter of the primary tumor greater than 1cm；
- ECOG score 0-1 points； -Have adequate baseline bone marrow and organ function reserve : absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 8g/dl; the ≥ 100000/mm3 hemoglobin concentration and serum creatinine ≤ 1.5 times the upper limit of normal ; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal , bilirubin ≤ 1.5 times the upper limit of normal ; left ventricular ejection fraction ( LVEF ) ≥ 50%
Who cannot join
- Non- invasive cancer patients;
- Inflammatory Breast Cancer patients;
- Metastatic breast cancer patients;
- HER2 positive patients;
- Ki67<14% patients;
- No adequateBaseline bone marrow or organ function reserve;
Show all 11Show fewer
- ECOG PS score ≥ 2 points;
- Younger than 18 years of age or greater than 70 years old;
- Already accepted therapy including chemotherapy , endocrine therapy or targeted therapy before neoadjuvant treatment;
- HER2-positive patients with left ventricular ejection fraction less than 55 % can not receiving Herceptin;
- Known allergy of docetaxel , capecitabine , epirubicin , ring phosphonamide .
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
Wen Ling Zhu, 13763316144, dearecho@msn.com
About this study
Official title: A Phase III，Randomized ，Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy
Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the group treated with XT protocol and the group with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the disease free survival(DFS) and overall survival(OS) of two subgroup.
Read the detailed description
Individualized treatment of breast cancer has become one of the main directions in the clinical and research areas of breast cancer,and the individualized treatment of the estrogen receptor(ER) positive patients which covered 65% of total cases is of vital importance. Historical research showed that among the ER-positive and HER2-negative breast cancer,Luminal B breast cancer with Ki67>14% is more likely to be benefited from chemotherapy,compared with the Luminal A breast cancer with Ki67<14%. And the results of our previous research showed that, the neoadjuvant XT protocol has more than 17% pCR rate in Luminal B subtype breast cancer.However,to those who didn't reach pCR,we've got no evidence whether switching to Anthracycline-based post operative protocol can benefit them.So that,we sketch out a randomized controlled multicentric phase III clinical trail.HER2 negative Luminal B subtype breast cancer patients are included. After 4 cycles of XT protocol neoadjuvant chemotherapy ,those who reach PR but not pCR are randomly divided into the group treated with XT protocol and the group with XEC protocol ,then compare the DFS and OS of two subgroup.
- Keywords
- HER2-negative Luminal B breast cancer
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 |
|---|---|---|
| pCR，XT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival after adjuvant chemotherapy within five years
Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.
Measured: Within 5 years after adjuvant chemotherapy
Overall survival after adjuvant chemotherapy within five years
Within 5 years after adjuvant chemotherapy,we should evaluate overall survival (OR)rates as the most important outcome measure.
Measured: Within five years after adjuvant chemotherapy
Secondary outcomes (1)
Imaging evaluation after neoadjuvant chemotherapy
After neoadjuvant chemotherapy,we should evaluate the status of patients as progress disease and then use the imaging evaluations as the proofs to plan their next therapeutic schedule or different grouping methods.
Measured: within the 21 days after neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Epidermal Growth Factor 2 Negative Carcinoma of BreastStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Anti-Cancer Association, Guangzhou General Hospital of Guangzhou Military Command, Guangzhou First People's Hospital
- Responsible party
- Principal investigator, Liao Ning, Guangdong Academy of Medical Sciences
- Investigators
- Liao Ning, MD,PhD, Study director, Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779531
- Sponsor's protocol ID
- GGHBCRG
- Status last verified
- Jan 2013
- First submitted
- 24 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III，Randomized ，Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01779531
- Acronym / sponsor ID
- GGHBCRG
- Keywords
- HER2-negative Luminal B breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Guangdong Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Chinese Anti-Cancer Association, Guangzhou General Hospital of Guangzhou Military Command, Guangzhou First People's Hospital
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Jan 2013 (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.
Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the group treated with XT protocol and the group with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the disease free survival(DFS) and overall survival(OS) of two subgroup.
Detailed description
Individualized treatment of breast cancer has become one of the main directions in the clinical and research areas of breast cancer,and the individualized treatment of the estrogen receptor(ER) positive patients which covered 65% of total cases is of vital importance. Historical research showed that among the ER-positive and HER2-negative breast cancer,Luminal B breast cancer with Ki67>14% is more likely to be benefited from chemotherapy,compared with the Luminal A breast cancer with Ki67<14%. And the results of our previous research showed that, the neoadjuvant XT protocol has more than 17% pCR rate in Luminal B subtype breast cancer.However,to those who didn't reach pCR,we've got no evidence whether switching to Anthracycline-based post operative protocol can benefit them.So that,we sketch out a randomized controlled multicentric phase III clinical trail.HER2 negative Luminal B subtype breast cancer patients are included. After 4 cycles of XT protocol neoadjuvant chemotherapy ,those who reach PR but not pCR are randomly divided into the group treated with XT protocol and the group with XEC protocol ,then compare the DFS and OS of two subgroup.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCR，XT | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 negative Luminal B subtype breast cancer patients
Key inclusion criteria (8 listed)
- Chinese population surgery patients with invasive breast cancer；
- Stage II-III；
- ER positive；
- HER2 negative；
- Ki67≥14%；
Key exclusion criteria (11 listed)
- Non- invasive cancer patients;
- Inflammatory Breast Cancer patients;
- Metastatic breast cancer patients;
- HER2 positive patients;
- Ki67<14% patients;
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
Disease free survival after adjuvant chemotherapy within five years
Time frame: Within 5 years after adjuvant chemotherapy
Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.
Overall survival after adjuvant chemotherapy within five years
Time frame: Within five years after adjuvant chemotherapy
Within 5 years after adjuvant chemotherapy,we should evaluate overall survival (OR)rates as the most important outcome measure.
1 secondary outcome
Imaging evaluation after neoadjuvant chemotherapy
Time frame: within the 21 days after neoadjuvant chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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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.
Liao Ning, MD,PhD study director
Guangdong Academy of Medical Sciences
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 Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Guangdong Academy of Medical Sciences 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 8 inclusion and 11 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 30 Jan 2013. 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?
Contact Liao Ning, MD,PhD (13903054106, drliao_ning@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival after adjuvant chemotherapy within five years (time frame: Within 5 years after adjuvant chemotherapy). The study lists 2 primary outcomes in all. 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 30 Jan 2013.