37 completed, 7 recruiting, 5 active not recruiting, 4 terminated. 28 Phase 3, 21 Phase 2, 2 Not applicable, 2 Phase 1, 1 Phase 4.
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib Chemotherapy followed by endocrine therapy and ribociclib treatment, De-escalation - Breast Cancer | Phase 3 | Recruiting | UNICANCER | 3902 | 2025-12-18 | 2026-05-26 |
| Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Olaparib + Elacestrant, Olaparib - Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer | Phase 2 | Recruiting | GBG Forschungs GmbH | 176 | 2024-12-13 | 2025-12-01 |
| Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer Capivasertib, Fulvestrant injection - CCCA Assessed by Ki67 Drop Below <2.7% From Baseline | Phase 2 | Recruiting | GBG Forschungs GmbH | 120 | 2024-12-04 | 2025-04-02 |
| Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer Inavolisib, PHESGO, Endocrine therapy - HER2-positive Breast Cancer | Phase 2 | Recruiting | GBG Forschungs GmbH | 170 | 2023-01-02 | 2026-09-11 |
| Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63) Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine - Triple Negative Breast Cancer | Phase 3 | Recruiting | Gilead Sciences | 1514 | 2022-12-12 | 2026-10-13 |
| Long-term Safety and Efficacy of GBG Study Participants Breast Cancer | Recruiting | GBG Forschungs GmbH | 400 | 2022-10-12 | 2026-09-15 | |
| A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) DS-8201a, T-DM1 - HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer | Phase 3 | Active not recruiting | Daiichi Sankyo | 1600 | 2020-12-04 | 2026-05-15 |
| Sacituzumab Govitecan in Primary HER2-negative Breast Cancer Capecitabine, Carboplatin, Cisplatin - HER2-negative Breast Cancer, Triple Negative Breast Cancer | Phase 3 | Active not recruiting | GBG Forschungs GmbH | 1332 | 2020-10-28 | 2026-04-22 |
| AXillary Surgery After NeoAdjuvant Treatment Breast Cancer | Recruiting | European Breast Cancer Research Association of Surgical Trialists | 3000 | 2020-04-28 | 2026-09-15 | |
| Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer Ribociclib, Anastrozole, Letrozole - Breast Cancer Metastatic | Phase 2 | Completed | GBG Forschungs GmbH | 56 | 2018-03-15 | 2023-07-07 |
| A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study). Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) - Metastatic Breast Cancer | Phase 4 | Completed | GBG Forschungs GmbH | 130 | 2018-03-01 | 2024-10-01 |
| Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer palbociclib, trastuzumab, pertuzumab - HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer | Phase 3 | Active not recruiting | Alliance Foundation Trials, LLC. | 518 | 2017-06-21 | 2026-02-12 |
| Denosumab as an add-on Neoadjuvant Treatment (GeparX) Denosumab, nab-Paclitaxel, Epirubicin - Breast Cancer Female NOS, Tubular Breast Cancer Stage II | Phase 2 | Completed | GBG Forschungs GmbH | 780 | 2017-02-13 | 2021-02-02 |
| Registry Trial to Evaluate the Clinical Utilization of Targeted Axillary Dissection (TAD) Not suitable for TAD, Suitable for TAD - Early Stage Breast Cancer | Completed | Kliniken Essen-Mitte | 548 | 2017-02-01 | 2021-02-03 | |
| Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency PwO, PwCb, EC - Breast Cancer, Triple Negative Breast Neoplasms | Phase 2 | Completed | GBG Forschungs GmbH | 107 | 2016-09-01 | 2020-03-17 |
| Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Chemotherapy in Triple Negative Breast Cancer MEDI4736 (Anti PD-L1), Placebo, nab-Paclitaxel - Breast Cancer | Phase 2 | Completed | GBG Forschungs GmbH | 174 | 2016-06-01 | 2021-02-15 |
| Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery no axillary surgery versus SLNB, SLNB versus completion ALND - Breast Cancer | Not applicable | Active not recruiting | University of Rostock | 5505 | 2015-09-01 | 2026-05-01 |
| Dose EScalation Induction of EvERolimus 3 weeks Dose Induction of Everolimus, 3 weeks Conventional Everolimus Dosing, Open Label Phase with conventional 10mg Everolimus Dosing week 4-24 - Breast Cancer, Hormone Receptor Positive Tumor | Phase 2 | Completed | GBG Forschungs GmbH | 156 | 2015-05-01 | 2022-02-23 |
| A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto) non-pegylated liposomal doxorubicin, Carboplatin, Paclitaxel - Tubular Breast Cancer Stage II, Tubular Breast Cancer Stage III | Phase 3 | Completed | GBG Forschungs GmbH | 961 | 2014-12-01 | 2017-07-13 |
| Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer without preoperative access to lymphoscintigraphy findings - Early-Stage Breast Carcinoma | Not applicable | Completed | Kliniken Essen-Mitte | 1198 | 2014-05-01 | 2020-07-09 |
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Breast Neoplasms (41) · Inflammatory Breast Neoplasms (5) · Carcinoma, Ductal, Breast (4) · Triple Negative Breast Neoplasms (4) · Neoplasm Metastasis (3) · Neoplasms (2) · Breast Neoplasms, Male (1) · Kenny-Caffey syndrome, Type 1 (1) · Patient Acceptance of Health Care (1) · Recurrence (1)
Cyclophosphamide (15) · Epirubicin (13) · Paclitaxel (12) · Capecitabine (11) · Trastuzumab (10) · Docetaxel (7) · 130-nm albumin-bound paclitaxel (6) · Carboplatin (5) · Doxorubicin (5) · Fulvestrant (5) · Bevacizumab (4) · Fluorouracil (4) · Letrozole (4) · Tamoxifen (4) · exemestane (4)
Germany (51) · Spain (12) · Austria (8) · France (8) · Italy (7) · Australia (6) · United States (6) · Belgium (5) · Ireland (5) · United Kingdom (5) · Canada (4) · South Korea (4) · Brazil (3) · Czechia (3) · Japan (3)
Sibylle Loibl, Prof. Dr. (3) · Gunter von Minckwitz, MD (2) · Gunter von Minckwitz, Prof. (2) · Gunter von Minckwitz, Prof. Dr. (2) · Johannes Holtschmidt, MD (2) · Manfred Kaufmann, MD (2) · Michael Untch, MD, Prof. (2) · Sibylle Loibl, MD, PhD (2) · Andreas Schneeweiss, MD, Prof. (1) · Bernd Gerber, MD (1) · Christoph Thomssen, MD (1) · Claus A Hanusch, MD, PhD (1)
PMID 22508812, PMID 34037241, PMID 34252375, PMID 38979716, PMID 12954578, PMID 15837982, PMID 16983592, PMID 17010609, PMID 18380893, PMID 18398097, PMID 19758440, PMID 19901111, PMID 20308670, PMID 20308671, PMID 20623180, PMID 21174610, PMID 21382868, PMID 21385882, PMID 21496284, PMID 22257523, PMID 22276820, PMID 22902483, PMID 23661292, PMID 24002511, PMID 24273046, PMID 24794243, PMID 25070172, PMID 25177258, PMID 25199759, PMID 25223482, PMID 25355716, PMID 25524798, PMID 25534375, PMID 25691671, PMID 26869049, PMID 27825007, PMID 28315068, PMID 28331237, PMID 28715532, PMID 28768217, PMID 28923573, PMID 29190004, PMID 29501363, PMID 29543566, PMID 29791287, PMID 30357310, PMID 30516102, PMID 30528802, PMID 31042410, PMID 31075727
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