BIG Breast International Group
We will find a cure for breast cancer through global research and collaboration.

BDPCC

Breast Disease Professional Committee of CMEA

BIG Voting Representative: Prof Jiandong Wang

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The China Medicine Education Association (CMEA) is a national level, academic non-profit organisation. The Breast Disease Professional Committee of CMEA (BDPCC) is a secondary branch of the CMEA, which was established on 30 January 2015. The BDPCC has 415 members, most of whom are breast surgeons, oncologists and pathologists. Our members come from over 300 hospitals, spread over 30 provinces in China.

The main activities of the BDPCC are to

1) offer continuing education to community physicians with the purpose to train them in breast disease treatment

2) hold the Breast Disease Multidisciplinary Symposium and the Great Wall Breast Cancer Conference every year

3) launch a multicentre prospective observational study, with the purpose of collecting breast cancer tissue samples for further sequencing and analysis

4) play a leading role in multicentre clinical trials in China and participate actively in international clinical trials.

BDPCC’s researchers believe that the collaboration with BIG will expedite international research and its impact on patients lives. Bringing local experience and knowledge, the BDPCC will contribute to better serve breast cancer physicians and patients, both in China and beyond 

 

You may visit their website here.


Interview with Prof Jiandong Wang

 

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Why did your group join the BIG network? What do you expect from this affiliation?

The vision of BDPCC is in accord with that of BIG: “We will find a cure for breast cancer through global research and collaboration”. What we are doing is pushing forward breast cancer therapy in China.  We aim to communicate and enhance coordination with the international community on scientific research and clinical trials.

Joining the BIG network, BDPCC is ready to collaborate with all the excellent investigators and outstanding institutions all over the world. We can work together to solve clinical problems and promote improved breast cancer therapy.

 

What are the biggest challenges for your group? Do you think that these are likely to be shared with other BIG member groups?

Chinese research institutes are playing more and more important roles at the international level. Meanwhile, the China Food and Drug Administration (CFDA) has already announced the“Fast-Track-Application” of new drugs. With BDPCC’s involvement in international research, we aim to reach a win-win situation for BIG and the trial sponsors.

By becoming a member of BIG, we would like to bond with other member groups and cooperate together in seeking further progress in breast cancer research and therapy.  

 

How are clinical trials run at the Breast Disease Professional Committee of CMEA? In which clinical trials or research programmes is your group currently involved?

BDPCC is a highly motivated group, affiliated with hospitals that have a high recruitment potential, which is crucial for the success of clinical trials. We have an extensive network of breast cancer investigators, with longstanding relationships between hospitals all over China. This allows quick access to principal investigators across a broad range of hospitals in China, and enables us to contribute to the successful recruitment of clinical trials.

BDPCC has the ability to sponsor trials with its member hospitals. We have already launched a prospective observational study with the objective to perform whole genome sequencing in patients with breast cancer. We also contract with other sponsors, such as pharmaceutical partners. A few examples of clinical trials that BDPCC affiliated hospitals have participated in with pharmaceutical sponsors (indicating the name of the trial / sponsor) are listed here after.

 

The BDPCC has recently launched the Chinese women gene signature screening programme. Could you tell us more about this programme and its objectives?

We launched the Chinese women gene signature screening programme on April 2016, which is a multicentre prospective observational study. The objectives of the study are to find the breast cancer related gene mutations in Chinese patients, as well as guide and support rapid development of individualised targeted drugs. We are aiming to enrol 20,000 Chinese patients with a primary diagnostic invasive ductal carcinoma of the breast; metastatic patients are excluded. Clinical data is collected at diagnosis, and patients are then followed-up for 10 years, with the aim to compare the primary tumour tissue with the para-tumour tissue and blood samples, which will be drawn before any treatment. 

We are planning to do the whole genome and RNA sequencing on the breast tumour samples. This will provide us with detailed information about the somatic mutations (SNP, Rearrangement), copy number variations and neoantigen analysis. Our aim is to unveil the mask of the gene signature of Chinese women with breast cancer

We have obtained Ethics Committee approval by The General Hospital of People’s Liberation Army (301 Hospitals) and the protocol, ICF, eCRF are being developed. We have recruited 40 hospitals across China, covering more than 30 provinces. We are now working on the legal documents translation and registration on clinicaltrials.gov (not yet finished). There are no related publications yet. 

 

Finally, what do you consider to be your group’s main achievements so far?

The BDPCC has achieved some good results, in areas such as academic research and technical communication, continuing education and training in district and community hospitals of China. The launch of the breast cancer gene mutation screening programme in China will promote precision therapy for Chinese women. 

Also important is the continuing education project of breast cancer diagnosis and treatment, “County education, China tour. This helps all BCPCC members to stay up to date with research information. 

Finally, individuals affiliated with the BDPCC have experience participating in international clinical trials with different sponsors, including major pharmaceutical companies.

 

Appendix (some clinical trials in which three BDPCC affiliated hospitals are currently involved)

Hospital

Time

Title

NCT ID

Sponsor

Status

Phase

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

2015

A Multicenter, Randomized, Double-blind Phase 3 Study Of Palbociclib (Oral Cdk 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Previously Untreated Asian Postmenopausal Women With Er (+), Her2 (-) Advanced Breast Cancer

NCT02297438

Pfizer

Recruiting

Phase 3

2016

A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment

NCT01702571

Hoffmann-La Roche

Recruiting

Phase 3

2016

Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin® in HER2-Positive, Locally Recurrent or Previously Untreated Metastatic Breast Cancer

NCT03084237

Shanghai Henlius Biotech

Recruiting

Phase 3

2016

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer

NCT02763566

Eli Lilly and Company

Recruiting

Phase 3

The 307th Hospital of Chinese People’s Liberation ArmyThe Affiliated Hospital of Military Medical Sciences

2016

 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer

NCT02763566

Eli Lilly and Company

Recruiting

Phase 3

2015

The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer

NCT02072512

Hospital Affiliated to Military Medical Science, Beijing

Unknown

Phase 2

The First Hospital of China Medical University

2017

Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin® in HER2-Positive, Locally Recurrent or Previously Untreated Metastatic Breast Cancer

NCT03084237

Shanghai Henlius Biotech

Recruiting

Phase 3

2012

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

NCT01602380

AstraZeneca

Active, not recruiting

Phase 3

  • The Highlight Yellow and Green are showing the hospitals are participating the same trial.

  • The red character indicate the Phase 2 trial.
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