1. Breast cancer ranks as the leading cancer in both global and Taiwanese female populations. The urgency to develop new drugs or treatment modalities is paramount. In Taiwan, there is a higher prevalence of premenopausal breast cancer compared to Western countries, making the development of treatment strategies tailored to Taiwanese women with breast cancer exceptionally important. Aimed to be a platform for Breast Cancer clinical trials in Taiwan, Taiwan Breast Cancer Consortium (TBCC), is formed.

2. The consortium has been proven to prompt collaboration with international pharmaceutical and biotechnology companies as well as institutions in oncology clinical trials for breast cancer.

3. We are also actively assisting Taiwan researchers to design investigators-initiated clinical trials, in line with international standards, and hope to let consortium become an excellent clinical trial alliance in Asia.

4. Exploring Consensus in Breast Cancer-Related Treatments

5. To establish a common information-related platform for data collection of breast cancer and clinical daily application for breast cancer

International Collaboration

• Collaboration with the Michelangelo Foundation in Italy for the NeoTRIP and APTneo trials. The research findings from NeoTRIP were published in Ann of Oncol 2022 (with Dr. Chiun-Sheng Huang as the second author). Enrollment for APTneo has concluded, and data analysis is currently underway

  

• Collaboration with Kyoto University in Japan, led by KBCRN, on KBCRN-B-003, aimed at evaluating the effectiveness of CDK4/6 inhibitors in neoadjuvant endocrine therapy. The trial has concluded, and results were presented at the 2022 San Antonio Breast Cancer Symposium (SABCS). The paper has been submitted for publication. Neoadjuvent hormonal therapy plus Palbociclib versus hormonal therapy plus placebo in women with operable, hormone sensitive and HER2-negative primary breast cancer, Cancer Res 1 March 2023; 83 (5_Supplement):P5–09–01. https://doi.org/10.1158/1538-7445.SABCS22-P5-09-01
• Participation in the third phase of the EXPERT clinical trial initiated by Breast Cancer Trials in Australia. Global enrollment has reached 68%, and Taiwan has already achieved its enrollment target of 78%.
• TBCC investigators are actively engaged in presenting research works from significant large-scale international multicenter clinical trials at international meetings and seminars, such as American Society of Clinical Oncology (ASCO); San Antonio Breast Cancer Symposium (SABCS); and ESMO Asia Congress.
• For international multicenter trials, TBCC investigators sit in Steering Committee in 14 trials, and took a role as Global Chair / Co-chair in 1.

Economic Benefits

• 1. Biosimilar Trastuzumab: Collaborating with local biotechnology company for a multicenter, double-blind Phase 3 trial involving biosimilar trastuzumab as neoadjuvant therapy for HER2-positive early-stage breast cancer patients. HER2-positive breast cancer accounts for 30% of all breast cancer cases. The National Health Insurance (NHI) partially covers the use of Trastuzumab Biosimilar for lymph node-negative HER2-positive early-stage breast cancer patients. The local biotechnology company obtained approval from the Taiwan Food and Drug Administration (TFDA) in May 2023 and anticipates NHI coverage by October 2023. Compared to Herceptin, trastuzumab biosimilar offers a more cost-effective option, benefiting a larger population of early-stage breast cancer patients and those with out-of-pocket expenses.
• 2. GLORIA Trial: Assisting local biotechnology company in conducting a Phase III, randomized, open-label trial using the anti-Globo H vaccine adagloxad simolenin (OBI-822)/OBI-821 as adjuvant therapy for high-risk early-stage Globo H-positive triple-negative breast cancer patients. The approach involves training the immune system to recognize a substance known as Globo H. Globo H is primarily found on the surface of breast cancer cells, rather than on healthy cells. Consequently, the immune system is trained to target and eliminate breast cancer cells that display Globo H on their surface. When administering cancer treatment vaccines, it is customary to combine them with another substance that may further enhance the immune system's response against cancer cells. In this trial, adagloxad simolenin (OBI-822) will be combined with an adjuvant (a substance used to amplify the response to the investigational drug). This adjuvant is referred to as OBI-821, an immune-enhancing substance.
• Olaparib Maintenance: Utilizing Olaparib for maintenance therapy in metastatic breast cancer patients with DNA repair-deficient disease after receiving cytotoxic chemotherapy.

Social Impact

• Through TBCC’s participation in clinical trials with domestic and international companies, members of the Breast Cancer Consortium (TBCC) will be invited to prominent international conferences, where they can present trial case reports and engage in discussions. Examples include the American Society of Clinical Oncology (ASCO), San Antonio Breast Cancer Symposium (SABCS), and ESMO Asia Congress.
• By participating in significant large-scale trials, principal investigators from alliance hospitals will have opportunities to publish papers in leading medical journals. This not only enhances Taiwan’s reputation in international breast cancer treatment but also increases Taiwan’s visibility on the global stage.
• MONALEESA 7: A Phase III randomized controlled trial in premenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer, comparing ribociclib in combination with hormone therapy to a placebo. The results extended the progression-free survival to 24 months when compared to the placebo (Lancet Oncol 2018, with Yen-Shen Lu as the corresponding author). This marked the first study confirming that CDK4/6 inhibitors significantly increase the overall survival rate of estrogen receptor-positive metastatic breast cancer (NEJM 2019), with Dr. Yen-Shen Lu as a joint first author. The final report revealed that the overall survival in the research group extended to 58 months, representing the longest treatment outcome in the history of premenopausal women with metastatic breast cancer (Clin Cancer Res 2022, with Dr. Yen-Shen Lu listed as the first author). 。
• Monarch E: A Phase III trial comparing the use of Abemaciclib in combination with endocrine therapy to the use of standard endocrine therapy alone in the treatment of high-risk, lymph node-positive early-stage estrogen receptor-positive, HER2-negative breast cancer. The results demonstrated a significant improvement in disease-free survival with the use of Abemaciclib. This study was published in the Annals of Oncology in 2021, with Dr. Chiun-Sheng Huang listed as the seventh author.
• Right Choice: A Phase II randomized controlled trial conducted on patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. The results demonstrated that the addition of Ribociclib to hormonal therapy significantly extended progression-free survival when compared to physician's choice chemotherapy. This groundbreaking study was orally presented by the first author, Yen-Shen Lu, at the 2022 San Antonio Breast Cancer Symposium (SABCS). Primary results from the randomized Phase II RIGHT Choice trial of premenopausal patients with aggressive HR+/HER2− advanced breast cancer treated with ribociclib + endocrine therapy vs physician’s choice combination chemotherapy. Presented at the 2022 San Antonio Breast Cancer Symposium (SABCS). December 6-10, 2022. Abstract # GS1-10.

  

  

• NATALEE: A Phase III, multicenter, randomized controlled trial conducted on patients with hormone receptor-positive, HER2-negative early-stage breast cancer. The sponsor’s press releases indicate that the combination of Ribociclib with endocrine therapy provides significant benefits to stage II and III breast cancer patients at risk of recurrence. The results of this trial are scheduled for presentation at ASCO in June 2023, with Chiun-Sheng Huang listed as the fourth author. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer: Primary results from the phase III NATALEE trial. Journal of Clinical Oncology 2023 41:17_suppl, LBA500-LBA500 DOI: 10.1200/JCO.2023.41.17_suppl.LBA500

Significant Milestone within the Consortium

• Professor Yen-Sheng Lu, in collaboration with our team, received support from Novartis Pharmaceuticals to design a large-scale international Phase III clinical trial. This trial involved the use of CDK 4/6 inhibitors in combination with hormone therapy in premenopausal women with metastatic breast cancer (MONALEESA 7 study), with six medical centers within the Breast Cancer Consortium (TBCC) participated in this trial. The final report revealed a significant extension of overall survival in the research group, from 48 to 58 months. This groundbreaking study marks the first-ever research confirming that targeted drugs in combination with hormone therapy can significantly increase the overall survival rate of estrogen receptor-positive metastatic breast cancer. It represents a crucial breakthrough in the field of breast cancer treatment in the past two decades.(Clinical Cancer Res, March 1;28(5), 851-859. DOI: 10.1158/1078-0432.CCR-21-3032.)
• Taiwan Breast Cancer Consortium (TBCC) has been fully engaged in international multi-center trials, in which 15 articles are published in top medical journals (NEJM, LANCET ONCOL., JCO) as TBCC investigators co-authored in the past 3 years. Such as Chiun-Sheng Huang listed as 2nd author in Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. New England Journal of Medicine 380, 617-628 (2019) and Yen-Sen Lu as co-first author in Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. New England Journal of Medicine 381, 307-316 (2019)
• In March 2023, participation in the St. Gallen Conference involved collaborative development of treatment guidelines for early-stage breast cancer treatment. The treatment guideline discussions from the 2021 St. Gallen Conference will be published in Ann Oncol in 2023. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Ann Oncol 32, 1216-1235 (2021)