3. Breast

3.1. Clinical Trial
- 3.1.1. Triple Negative (TNBC)
  - 3.1.1.1. Early Stage
  - 3.1.1.2. Advanced Stage
- 3.1.2. HER2+ve
  - 3.1.2.1. Early Stage
  - 3.1.2.2. Advanced Stage
- 3.1.3. ER+ve & HER2-ve
  - 3.1.3.1. Early Stage
  - 3.1.3.2. Advanced Stage
3.2. Supportive Cancer Care
3.3. Data Science
3.4. Basic Research

3.0 Breast
3.1 Clinical Trial
3.1.1 Triple Negative (TNBC)
3.1.1.1.1 Early Stage
Specific Selection Criteria: Glob H-Positive
Adjuvant treatment: Phase 3		Immunotherapy (Globo H-KLH immunostimulant)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
The GLORIA Study (Protocol ID: OBI-822-011): A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients with High-Risk, Early-Stage Globo H-Positive Triple Negative Breast Cancer.	Key Inclusion Criteria: Histologically documented TNBC (ER/PR ≤5% cells). High risk deﬁned as: ≥1 cm residual primary or ≥1 residual axillary node after neoadjuvant chemotherapy. OR Pathological Stage IIB or III disease treated with adjuvant chemotherapy alone Received ≥4 cycles of standard taxane- and/or anthracycline-based chemotherapy.	Adagloxad Simolenin (Globo H-KLH immunostimulant) + OBI-821 Vs. SOC.	Dr. Wendy CHAN	Department of Clinical Oncology	winglok@hku.hk	Bryan Yun 2255 5124
3.1.1 Triple Negative (TNBC)
3.1.1.2.1 Locally Advanced or Metastatic, Unresectable
Specific Selection Criteria: PD-L1-ve (Cohort 1), PD-L1+ve (Cohort 2)
First-line (Cohort 1), Second to Third-line (Cohort 2) treatment: Phase 2		Immunotherapy (Anti-CD47 Antibody)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
A phase 2 Study of magrolimab combination therapy in patients With unresectable, locally advanced or metastatic triple-negative breast cancer.	Key Inclusion criteria: Cohort 1: Individuals with previously untreated unresectable locally advanced or metastatic TNBC that are considered PD-L1 negative (as determined by an approved test according to local regulations). Cohort 2: Individuals with unresectable, locally advanced or metastatic TNBC who have received at least 1 and no more than 2 prior lines of therapy in the unresectable, locally advanced or metastatic setting. Individuals must have been previously treated with a taxane in any setting. Individuals with tumors that are considered positive for PD-L1 expression (as determined by an approved test according to local regulations) must have received an immune checkpoint inhibitor for a prior-line of treatment for unresectable locally advanced/metastatic TNBC.	Magrolimab (Anti-CD47 Monoclonal Antibody) + Nab-Paclitaxel or Paclitaxel (Chemo) Vs. Nab-Paclitaxel or Paclitaxel (Chemo)	Dr. Joanne Chiu	Department of Medicine (Medical Oncology)	jwychiu@hku.hk	2255 5582
3.1.1 Triple Negative (TNBC)
3.1.1.2.2 Locally advanced or Metastatic, Unresectable
First-line treatment: Phase 3		Targeted Therapy (Anti-Trop-2 ADC), Immunotherapy (Anti-PD-1 Antibody)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
ASCENT-04 (Protocol ID: GS-US-592-6173): A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1.	Key Inclusion Criteria: Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening. Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. Individuals presenting with de novo metastatic TNBC are eligible for this study. TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.	Sacituzumab govitecan-hziy (SG) (Antibody drug conjugate) + Pembrolizumab (Anti-PD-1 monoclonal Antibody) Vs. Pembrolizumab (Anti-PD-1 monoclonal Antibody) + Treatment of Physician's Choice (TPC)	Dr. Joanne Chiu	Department of Medicine (Medical Oncology)	jwychiu@hku.hk	2255 5582
3.1.1 Triple Negative (TNBC)
3.1.1.2.3 Locally Advanced or Metastatic, Unresectable
Specific Selection Criteria: PD-L1-ve (For Untreated), PD-L1+ve (For Previously Treated with Anti-PD-L1 Agents)
First-line and Second-line treatment: Phase 3		Targeted Therapy (Anti-Trop-2 ADC)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
ASCENT-03 (Protocol ID: GS-US-592-6238): A Randomized, Open-label, Phase 3 Study of sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1.	Key Inclusion criteria: Previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC). Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo)adjuvant setting.	Sacituzumab Govitecan (Anti-Trop-2-ADC) Vs. Paclitaxel/nab-Paclitaxel/ Gemcitabine (Chemo) + Carboplatin (Chemo)	Dr. Wendy Chan	Department of Clinical Oncology	winglok@hku.hk	Bryan Yun 2255 5124

3.1.2 HER2+ve
3.1.2.1 Early Stage
Specific Selection Criteria: Non-pCR after neoadjuvant treatment
Adjuvant treatment: Phase 3		Targeted Therapy (Anti-HER2 ADC)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
DESTINY-Breast05 (Protocol ID: DS8201-A-U305) A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy.	Key Inclusion Criteria: Pathologically documented HER2-positive breast cancer (BC). Completion of neoadjuvant systemic chemotherapy, including taxane and HER2-directed treatment prior to surgery. Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the following high-risk criteria: Inoperable breast cancer at presentation (prior to neoadjuvant therapy), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0. Operable at presentation, defined as clinical stages T1-3, N0-1, M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy.	Trastuzumab Deruxtecan (T-DXd) (Anti-HER-2 Antibody drug conjugate) Vs. Trastuzumab Ematansine (T-DM1) (Anti-HER-2 Antibody drug conjugate)	Dr. Wendy Chan	Department of Clinical Oncology	winglok@hku.hk	Emina CHEUNG 2255 5124

3.1.2 HER2+ve
3.1.2.2 Locally Advanced or Metastatic
Specific Selection Criteria: PIK3CA-Mutated HER2+ve, after first-line induction therapy
Maintenance Therapy: Phase 3		Targeted Therapy (PI3Kα Inhibitor/ Anti-HER2 antibody)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer.	Key Inclusion Criteria: Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection. Confirmation of HER2 biomarker eligibility. Confirmation of PIK3CA-mutation biomarker.	Inavolsib (PI3Kα Inhibitor) + Phesgo (Anti-HER2 antibody) Vs Placebo + Phesgo	Dr. Wendy Chan	Department of Clinical Oncology	winglok@hku.hk	Bryan Yun 2255 5124

3.1.3 ER+ve, HER2-ve
3.1.3.2.1 Locally Advanced or Metastatic, Unresectable
Second-line treatment: Phase 3		Targeted Therapy (PI3K inhibitor/ CDK Inhibitor), Hormonal therapy (Estrogen receptor antagonist)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
INAVO120 (Protocol ID: WO41554): A Phase III, Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib And Fulvestrant Versus Placebo Plus Palbociclub and Fulvestrant in Patients with PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer.	Key Inclusion Criteria: Diagnosis of HR+/HER2- breast cancer. Metastatic or locally advanced disease not amenable to curative therapy. Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen. Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal.	GDC-0077 (PI3K inhibitor) Vs. Placebo (Co-admin: Palbociclib - Cyclin-dependent kinase (CDK) inhibitor, Fulvestrant - Estrogen receptor antagonist)	Dr. Roland Leung	Department of Medicine (Medical Oncology)	medicaloncology@hku.hk	2255 5582

3.1.3 ER+ve, HER2-ve
3.1.3.2.2 Locally Advanced or Metastatic, Unresectable
Second-line or Subsequent-line treatment: Phase 3		Targeted Therapy (Anti-Trop-2 ADC), Chemotherapy
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator	Department	Email	Contact number
ASCENT-07 (Protocol ID: GS-US-598-6168): A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy.	Key Inclusion Criteria: Documented evidence of HR. Documented evidence of HER2- status. Disease progression on at least 2 or more previous lines of endocrine therapy (ET). Disease progression within 6 months of starting first-line ET	Sacituzumab govitecan (Anti-Trop-2 ADC) Vs Paclitaxel/ nab-paclitaxel/ capecitabine	Dr. Wendy Chan	Department of Clinical Oncology	winglok@hku.hk	Bryan Yun 2255 5124

3.0 Breast
3.2.1 Supportive Cancer Care
Early Stage
Specific Selection Criteria: Completed hospital-based adjuvant treatments including radiotherapy and chemotherapy, within the past 18 months.
Study Title	Main Inclusion/Exclusion	Principal Investigator	Department	Email	Contact number
Managing fear of cancer recurrence: a qualitative comparison of coping process among Chinese breast cancer survivors with nonclinical, subclinical, and clinically-significant fear of cancer recurrence.	Key Inclusion Criteria: Are Cantonese- or Mandarin-speakers. Are recently diagnosed with breast cancer or colorectal cancer, without metastatic disease. Have had surgery as a primary treatment within the past 24 months. Have completed hospital-based adjuvant treatments including radiotherapy and chemotherapy, within the past 18 months. Key Exclusion Criteria: Patients who are illiterate, diagnosed with metastatic cancer, currently have with depression or psychosis, and are currently receiving psychological treatment will be excluded.	Dr. Danielle WL Ng	School of Public Health	dwlng@hku.hk	3917 9897
3.2.2 Supportive Cancer Care
Early Stage
Specific Selection Criteria: Between 1st and 2nd cycle of neoadjuvant or adjuvant chemotherapy.
Trajectories of chemotherapy-induced peripheral neuropathy and the role of psychological factors among cancer patients.	Key Inclusion Criteria: Are Cantonese- or Mandarin-speakers. Are recently diagnosed with non-metastatic breast, colorectal or ovarian cancer. Are in early chemotherapy stage (i.e. will undergo neo-adjuvant or adjuvant chemotherapy or between the first and second cycle of chemotherapy. Key Exclusion Criteria: Non-Chinese ethnicity; metastatic cancer; have completed chemotherapy or are currently undergoing the second cycle of chemotherapy.	Dr. Wendy WT Lam	Li Ka Shing Faculty of Medicine	jchanay@hku.hk	3910 2480
3.2.3 Supportive Cancer Care
Early Stage
Specific Selection Criteria: Scheduled to commence their first cycle of outpatient adjuvant chemotherapy
Study Title	Main Inclusion/Exclusion	Principal Investigator	Department	Email	Contact number
Effects of Self-administered Acupressure in Cancer Patients undergoing Chemotherapy: A Randomized Controlled Trial.	Key Inclusion Criteria: Patients are eligible if they are aged 18 or above with a diagnosis of breast cancer scheduled to commence their first cycle of outpatient adjuvant chemotherapy. Cooperative Oncology Group performance status of 0 or 1, and screened as no contraindications for exercise based on a pre-exercise safety assessment. Key Exclusion Criteria: Received/self-administered acupressure or acupuncture in the previous 3 months. Have engaged in >90 min of moderate intensity aerobic exercise per week in the previous 3 months. Are pregnant or lactating. Have any injury or ulcers around the acupoints. Unable to communicate in Cantonese, Mandarin, or English.	Dr. Denise Shuk Ting Cheung	School of Nursing	denisest@hku.hk	3917 6673

3.2.4 Supportive Cancer Care
Early Stage
Specific Selection Criteria: completed adjuvant treatments within the past 18 months
The effect of metacognition-based, manualized intervention on fear of cancer recurrence: a randomized controlled trial	Key Inclusion Criteria: Cantonese-speaking or Mandarin-speaking Chinese patients who: are over the age of 18 years, are recently diagnosed with curable (stages 0–III) breast cancer, colorectal or gyanecological cancer, have surgery as a primary treatment, have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past 18 months, with the cut-off scored ≥13 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) and are able to read and write will be recruited. Key Exclusion Criteria: Non-Chinese ethnicity; metastatic cancer; with a current diagnosis of depression or psychosis or are currently receiving psychological treatments; and with language difficulties or intellectual disability.	Dr. Wendy WT Lam	School of Public Health	wwtlam@hku.hk	3917 9878

3.0 Breast
3.3.1 Data Science
Specific Selection Criteria: Early stage, completed the last treatments within the past 18 months
Study Title	Main Inclusion/Exclusion	Principal Investigator	Department	Email	Contact number
The role of intolerance of uncertainty and negative metacognitive beliefs in fear of cancer recurrence: a longitudinal study.	Key Inclusion Criteria: Are Cantonese- or Mandarin-speakers. Are recently diagnosed with breast cancer or colorectal cancer, without metastatic disease. Have completed the last treatments (surgery or post adjuvant-treatment excluding hormonal and targeted therapy) within the past 18 months. Key Exclusion Criteria: Metastatic cancer.	Dr. Wendy WT Lam	School of Public Health	wwtlam@hku.hk	3917 9878
3.0 Breast
3.4.1 Basic Research
Study Title	Main Inclusion/Exclusion	Principal Investigator	Department	Email	Contact number
Breast cancer risks following antipsychotic use in women with bipolar disorder versus schizophrenia: A territory-wide nested case-control study spanning two decades.	Key Inclusion criteria: Women with schizophrenia only or bipolar disorder only. No breast cancer history.	Dr. Francisco T.T. Lai	Department of Pharmacology and Pharmacy	fttlai@hku.hk	3910 3836
3.4.2 Basic Research
BQ323636.1 a predictive marker for aromatase inhibitor resistance in Estrogen and Androgen Receptor positive breast cancer.	Key Inclusion Criteria: ER and AR +ve breast cancer patients receiving non-steroidal AI treatment; patients may have switched from tamoxifen treatment or vice versa. Key Inclusion Criteria: Receiving concurrent chemotherapy.	Prof. Ui Soon Khoo	Department of Pathology	uskhoo@hku.hk	2255 2664
3.4.3 Basic Research
Functional characterization of AKTIP in breast cancer		Dr. Lydia Wai Ting Cheung	School of Biomedical Sciences	lydiacwt@hku.hk	Dr Lydia Wai Ting Cheung 3917 6908
3.4.4 Basic Research
Pharmacological effect of Garcinone E on triple negative breast cancer.		Dr. George P.H. Leung	Department of Pharmacology and Pharmacy	gphleung@hku.hk	3917 6861

Cancer Research in HKUMed3. Breast

Cancer Research in HKUMed
3. Breast