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. 2022 Jun 11;23(12):6547. doi: 10.3390/ijms23126547

Table 2.

Clinical trials with CDK4/6 inhibitors (CDKi) in HER2+ breast cancer **.

Trial (NCT ID) Arms Phase, Expected Enrolment & Site Primary Outcome Setting
CDKi, ribociclib in
combination with trastuzumab Or T-DM1 for advanced/metastatic HER2-positive breast cancer (NCT02657343) [80]

  1. Ribociclib+T-DM1

  2. Ribociclib + Trastuzumab

  3. Ribociclib + Trastumzab + Fulvestrant

 Phase Ib/II
N = 25
USA		 Maximum Tolerated Dose (MTD) and/or recommended
Phase2 Dose (RP2D)
Clinical Benefit Rate (CBR) 		Metastatic
Ribociclib with trastuzumab plus letrozole in
postmenopausal HR+, HER2-positive advanced breast cancer patients (NCT03913234)

  1. Letrozole + Trastuzumab + Ribociclib

 Phase Ib/II
N = 95
South Korea		 Progression-free survival Metastatic
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (NCT03530696)

  1. T-DM1 + Palbociclib

 Phase II
N = 46
USA		 Progression-free survival Metastatic
Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in ER-positive, HER2-positive breast cancer (neoPEHP) (NCT04858516)

  1. Palbociclib + Exemestane + Trastuzumab + Pyrotinib

 Phase II
N=57
China		 Pathological complete response Neoadjuvant
To reduce the use of chemotherapy in postmenopausal patients with ER-positive and HER2-positive breast cancer (TOUCH) (NCT03644186) [81]

  1. Control arm: Paclitaxel + Trastuzumab + Pertuzumab

  2. Palbociclib + Letrozole + Trastuzumab + Pertuzumab

 Phase II
N = 144
Belgium, France, Italy, Switzerland		 Pathological complete response Neoadjuvant
Palbociclib, trastuzumab, lapatinib, and fulvestrant treatment in patients with brain metastasis for ER-positive, HER2-positive breast cancer (NCT04334330)

  1. Palbociclib + Trastuzumab + Lapatinib + Fulvestrant

 Phase II
N = 34
China		 Objective response rate in the CNS Metastatic (Brain)
Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) (NCT02947685) [82]

  1. Palbociclib + anti-HER2 therapy (Trastuzumab/Pertuzumab) + Endocrine Therapy (Letrozole, Anastrozole, Exemestane OR Fulvestrant)

  2. Control arm: Anti-HER2 therapy (Trastuzumab/Pertuzumab) + Endocrine Therapy (Letrozole, Anastrozole, Exemstane OR Fulvestrant)

 Phase III
N = 496
Multiple centers worldwide		 Progression-free survival (PFS) Metastatic
Tucatinib, Palbociclib, and Letrozole in Metastatic Hormone Receptor-Positive and HER2-positive Breast Cancer (NCT03054363) [83]

  1. Tucatinib + Palbociclib + Letrozole

 Phase Ib/II
N = 42
USA		 Phase 1b adverse events (AE)
Progression-free survival (PFS)
 Metastatic
Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer (PATRICIA II) (NCT02448420) [84]

  1. Palbociclib + Trastuzumab (HR-/HER2+)

  2. Palbociclib + Trastuzumab (HR+/HER2+)

  3. Trastuzumab + Palbociclib + Letrozole (HR+/HER2+)

  4. Palbociclib, trastuzumab, and endocrine therapy (Aromatase Inhibitor, Fulvestrant, or Tamoxifen) for HR-positive, HER2 positive, Luminal intrinsic subtype (PAM50)

  5. Control arm: Physician’s choice (T-DM1 or chemotherapy [gemcitabine, vinorelbine, capecitabine, eribulin or taxane] + trastuzumab or endocrine therapy + trastuzumab) for HR-positive, HER2 positive, Luminal intrinsic subtype (PAM50)

 Phase II
N = 102
Spain		 Progression-Free Survival (PFS) Metastatic
Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HER2-positive, HER2-positive Metastatic Breast (NCT03304080)

  1. Anastrozole + Palbociclib + Trastuzumab + Pertuzumab

 Phase I/II
N = 36
USA		 Dose-Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD)
Clinical Benefit Rate (CBR)		 Metastatic
T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer (NCT04351230)

  1. Control arm: T-DM1

  2. T-DM1 + Abemaciclib

 Phase II
N = 0
(Withdrawn)
USA		 Progression-free survival (PFS) Metastatic
Pyrotinib, Letrozole and SHR6390 in ER+/HER2+ Advanced Breast Cancer (PLEASURABLE) (NCT03772353) [85]

  1. Pyrotinib + Letrozole + Dalpiciclib (CDKi) (SHR6390)

  2. Pyrotinib + Fulvestrant + Dalpiciclib

 Phase I/II
N = 79
China		 Phase 1b adverse events (AE)
Progression-free survival (PFS)		 Metastatic
Pyrotinib with CDKi SHR6390 for Trastuzumab-treated Advanced HER2-Positive Breast Cancer (INPHASE) (NCT04095390)

  1. HR+/HER2+: Pyrotinib + Dalpiciclib + Letrozole

  2. HR-/HER2+: Pyrotinib + Dalpiciclib + Capecitabine

  3. HR-/HER2+: Pyrotinib + Dalpiciclib

 Phase II
N = 60
China		 Objective Overall Response Rate (ORR) Metastatic

** This table was prepared based on the information publicly available in the National Clinical Trials (NCT) registry and is subject to change (https://www.clinicaltrials.gov/, (accessed on 7 June 2022)).