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IBRANCE 100 mg film-coated tablets

DRUG13 trials

Sponsors

F. Hoffmann-La Roche AG, AstraZeneca AB, European Organisation For Research And Treatment Of Cancer, ETOP IBCSG Partners Foundation, Medica Scientia Innovation Research S.L.

Conditions

Advanced Breast CancerBreast cancerESTROGEN RECEPTOR-POSITIVEEndocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-MutatedEstrogen Receptor-PositiveEstrogen receptor (ER)-positiveFemale or male patients with histologically confirmed HR-positiveHER-2 negative Advanced Breast Cancer

Phase 2

A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients with Persistent or Recurrent Rare Epithelial Ovarian Tumors
Active, not recruitingCTIS2023-508194-89-00
F. Hoffmann-La Roche AGPersistent or Recurrent Rare Epithelial Ovarian Tumors
Start: 2021-08-30Target: 57Updated: 2026-01-06
EORTC-1745-ETF-BCG: A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALACHES)
Active, not recruitingCTIS2023-505223-31-00
European Organisation For Research And Treatment Of CancerLocalized ER+ breast cancer
Start: 2019-06-14Target: 347Updated: 2025-09-03
Palbociclib plus fulvestrant in women with hormone receptor positive and human epidermal growth factor receptor type 2 negative locally advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor in combination with hormonal therapy: a multicenter, phase II trial
RecruitingCTIS2024-513372-18-00
Consorzio Oncotech, Consorzio OncotechPre- and post-menopausal women with HR+/HER2- LABC or MBC whose disease has progressed to CDK4/6 inhibitor in combination with a hormonal therapy in the adjuvant or metastatic setting
Start: 2019-10-18Target: 168Updated: 2024-05-29
A randomized phase II study to evaluate the safety and efficacy of trastuzumab deruxtecan versus CDK4/6 inhibitor-based endocrine therapy as first-line therapy of HR-positive and HER2-low/ultra-low advanced breast cancer patients classified as non-luminal subtype according to gene expression profiling (The PONTIAC Study).
RecruitingCTIS2024-512360-55-00
Medica Scientia Innovation Research S.L.Unresectable locally recurrent or metastatic hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-low/ultralow breast cancer classified as non-luminal by gene expression profiling.
Start: 2025-06-30Target: 194Updated: 2026-01-16

Phase 3

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
RecruitingCTIS2023-504997-39-00
AstraZeneca ABHormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
Start: 2021-06-14Target: 214Updated: 2026-01-26
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
RecruitingCTIS2022-502980-39-00
F. Hoffmann-La Roche AGEstrogen receptor (ER)-positive, HER2-negative advanced breast cancer
Start: 2024-01-25Target: 296Updated: 2026-01-13
SERENA-4: A Randomised, Multicentre, Double-Blind, Phase 3 Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrazole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
Active, not recruitingCTIS2023-503995-26-00
AstraZeneca ABEstrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Start: 2021-05-11Target: 499Updated: 2025-12-15
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Active, not recruitingCTIS2023-506911-16-00
F. Hoffmann-La Roche AGESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Start: 2020-12-04Target: 259Updated: 2025-12-16
POLAR: A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer
Active, not recruitingCTIS2024-510776-20-00
ETOP IBCSG Partners FoundationFemale or male patients with histologically confirmed HR-positive, HER2-negative resected isolated locoregional recurrence (ILRR) of breast cancer.
Start: 2019-10-25Target: 381Updated: 2025-08-18
SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor A ctDNA Guided Early Switch Study
Active, not recruitingCTIS2023-503990-39-00
AstraZeneca ABEstrogen Receptor-Positive, HER-2 negative Advanced Breast Cancer
Start: 2021-09-30Target: 128Updated: 2025-09-24
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01).
RecruitingCTIS2023-504180-16-00
AstraZeneca ABAdvanced Breast Cancer
Start: 2025-04-07Target: 136Updated: 2025-12-29
Selecting the optimal position of CDK4/6 inhibitors in HR+ advanced breast cancer: the SONIA trial
Active, not recruitingCTIS2024-516204-42-00
BOOG Study Center B.V.Breast cancer
Start: 2017-11-21Target: 1050Updated: 2024-11-12
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients with Endocrine-Sensitive PIK3CA -Mutated, Hormone Receptor-Positive, HER2- Negative Advanced Breast Cancer
RecruitingCTIS2024-516162-11-00
F. Hoffmann-La Roche AGEndocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-Mutated, Hormone Receptor-Positive, human epidermal growth factor receptor 2- (HER2-) negative advanced breast cancer
Start: 2025-07-14Target: 176Updated: 2025-11-10