Cancer Research in HKUMed
3. Breast

3.0 Breast

3.1 Clinical Trial

3.1.1 Triple Negative (TNBC)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

(Protocol ID: MK2870-012)

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

Key Inclusion Criteria:

1. Has centrally confirmed TNBC.

2. Has no evidence of locoregional or distant relapse.

3. Had neoadjuvant treatment based on the KEYNOTE-522 regimen.

4. Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery.

Pembrolizumab + MK2870

Vs.

Treatment of Physician’s Choice (TPC)

Prof. Rina Hui

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

Trofue-032 (Protocol ID: MK2870-032)

A Phase 3, Randomized, Open-label, Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/ Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple Negative Breast Cancer or Hormone Receptor-low Positive/ Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Key Inclusion Criteria:

5. Has centrally confirmed TNBC and Trop-2.

6. No previous systemic therapy

7. No metastases

Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery.

Study Arm: Pembrolizumab + MK2870+ paclitaxel + carboplatin in neoadjuvant -> pembrolizumab +/- optional TPC in adjuvant

Vs.

SOC arm: Keynote 522 in neoadjuvant -> pembrolizumab +/- optional TPC for adjuvant

Prof. Rina Hui

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

Tropion-Breast-05 (Protocol ID: D7630C0001)

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared with Investigator’s Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Key Inclusion Criteria:

1. Previously untreated locally recurrent inoperable or metastatic TNBC

2. PD-L1 centrally confirmed

Dato-Dxd + Durvalumab

Vs.

Investigator’s Choice Chemotherapy + Pemrbolizumab

Dr. Roland Leung

Department of Medicine (Medical Oncology)

cancermed@hku.hk

2255 4361

2255 1661

3.1.3 ER+ve, HER2-ve

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

OPERA-01 (Protocol ID: OP-1250-301)

A phase 3 randomized, open-label study of OP-1250 monotherapy vs standard of care for the treatment of ER+, HER2– advanced or metastatic breast cancer following endocrine and CDK 4/6 inhibitor therapy.

Key Inclusion Criteria:

1. ER+, HER2– breast cancer.

2. Previously received 1 or 2 lines ET as monotherapy or in combination with

a CDK 4/6 inhibitor.

OP-1250 monotherapy

vs.

SOC (Fulvestrant/ Letrozole/ Anastrozole/ Exemestane)

Dr. Wendy Chan

Dr. Roland Leung

Department of Clinical Oncology

Department of Medicine (Medical Oncology)

winglok@hku.hk

cancermed@hku.hk

Alex MAK

2255 4216

2255 4361 2255 1661

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

OPERA-02 (Protocol ID: OP-1250-302)

A Phase 3 Randomised, Double-Blind, Active-Controlled Study of Palazestrant with Ribociccib Versus Letrozole with Ribociclib for the First- Line Treatment of ER+, HER2- Advanced Breast Cancer

Key Inclusion Criteria:

1. Unresectable locally advanced or metastatic centrally-confirmed HR+/HER2- breast cancer.

2. Disease recurrence on/after CDK4/6i (in the early or metastatic setting).

Key Exclusion Criteria:

1. Previously treated with chemotherapy in metastatic setting.

2. Disease recurrence within 6 months after completion adjuvant /neoadjuvant chemotherapy.

Arm A:

Palazestrant + Ribociclib + Letrozole matching placebo

Vs.

Arm B: Letrozole + Ribociclib + Palazestrant matching placebo

Prof. Rina Hui

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

(Protocol ID: OP-3136-101)

A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants with Advanced or Metastatic Solid Tumors

Key Inclusion Criteria: (for part 1)

1. Participants with breast cancer must have ER+ HER2- breast confirmed by local laboratory testing.

2. Progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting

Key Exclusion Criteria:

1. Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a spinal cord compression

OP-3136 monotherapy

Prof. Rina Hui

Centre of cancer medicine

cancermed@hku.hk

2255 4361

2255 1661

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

PionERA (Protocol ID: CO44657):

A Phase III, randomized, open-label study evaluating efficacy and safety of Giredestrant compared with Fulvestrant, both combined with a CDK4/6 inhibitor, in patients with Estrogen Receptor-Positive, HER2-Negative advanced breast cancer with Resistance to prior Adjuvant Endocrine Therapy.

Key Inclusion Criteria:

1. Diagnosis of HR+/HER2- breast cancer.

2. Resistance to prior adj ET (+- CDK4/6i).

3. Relapse on adj tx after >= 12 months or off-tx with treatment-free interval <= 12 months.

4. Centrally confirm ESR1 positive

Giredestrant +- Palbociclib/Ribociclib/Abemaciclib

Vs.

Fulvestrant +- Palbociclib/Ribociclib/Abemaciclib

Dr. Roland Leung

Department of Medicine (Medical Oncology)

cancermed@hku.hk

2255 4361 2255 1661

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:

1. 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.

2. 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:

1. Received/self-administered acupressure or acupuncture in the previous 3 months.

2. Have engaged in >90 min of moderate intensity aerobic exercise per week in the previous 3 months.

3. Are pregnant or lactating.

4. Have any injury or ulcers around the acupoints.

5. Unable to communicate in Cantonese, Mandarin, or English.

Dr. Denise Shuk Ting Cheung

School of Nursing

denisest@hku.hk

3917 6673

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:

1. Are Cantonese- or Mandarin-speakers.

2. Are recently diagnosed with breast cancer or colorectal cancer, without metastatic disease.

3. Have completed the last treatments (surgery or post adjuvant-treatment excluding hormonal and targeted therapy) within the past 18 months.

Key Exclusion Criteria:

1. Metastatic cancer.

Dr. Wendy WT Lam

School of Public Health

wwtlam@hku.hk

3917 9878

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:

1. Women with schizophrenia only or bipolar disorder only.

2. No breast cancer history.

Dr. Francisco T.T. Lai

Department of Pharmacology and Pharmacy

fttlai@hku.hk

3910 3836

BQ323636.1 a predictive marker for aromatase inhibitor resistance in Estrogen and Androgen Receptor positive breast cancer.

Key Inclusion Criteria:

1. 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:

1. Receiving concurrent chemotherapy.

Prof. Ui Soon Khoo

Department of Pathology

uskhoo@hku.hk

2255 2664

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

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