Studies in Treatment Phase & Follow-up
ABCSG 39 / Aphinity
A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer.
ABCSG 41 / OlympiA
A randomised, double-blind, parallel group, placebo-controlled multi-centre phase III study to assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2-negative breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
ABCSG 42 / PALLAS
PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer
ABCSG 43 / INSEMA
Comparison of axillary sentinel lymph node biopsy versus no axillary surgery in patients with stage I and II invasive breast cancer and breast-conserving surgery: a randomized prospective surgical trial
ABCSG 45
A prospective, open, randomized, phase II study of carboplatin/ olaparib in the pre-operative treatment of patients with triple-negative primary breast cancer which exhibit the features of positive homologous recombination deficiency (HRD) status
| Coordinating Investigator: | Christian Singer, Vienna |
| Start of study | 11/2019 |
| Sample size: | 90 (national) |
| Sponsor: | ABCSG |
Description and status:
ABCSG 45 is an open, randomized phase II study, aiming to enroll 90 patients with early triple-negative breast cancer and homologous recombination deficiency (HRD) in their tumor tissue. The patients are randomized 1:1 to either receive neoadjuvant treatment with the PARP inhibitor olaparib, in combination with carboplatin, or a neoadjuvant taxane- / anthracycline-based chemotherapy (TAC) consisting of doxorubicin or epirubicin, docetaxel and cyclophosphamide. The study consists of 2 sub-phases: in dose-finding phase 1, the maximum tolerated olaparib dose was assessed in 20 patients at 6 sites and the identified olaparib dose is then administered in phase 2, with an additional 70 patients at 9 sites. The primary endpoint of ABCSG 45 is the central evaluation of the residual cancer burden (RCB) after surgery following neoadjuvant treatment to compare the efficiency of 6 cycles of olaparib / carboplatin with 6 cycles of TAC. Furthermore, the pathological complete remission (pCR) is assessed and the quality of life outcomes of participants are recorded using EORTC questionnaires. Dose-finding phase 1 was completed with 20 patients by the end of 2020 and the identified optimal olaparib dose was then used in study phase 2, which has been open for recruitment of additional 70 patients from June 2021 to December 2023. The final 90th patient was enrolled on December 13th, 2023 and recruitment closed.
In Q1/2023, an optional substudy was implemented, which gives patients who complete main study treatment the option to continue with adjuvant intake of daily olaparib for one year. This substudy design was based on the promising OlympiA study results published in 2022 (Geyer et al., Ann. Oncol.), which showed an extension of overall survival after one year of adjuvant olaparib treatment. A total of 20 ABCSG 45 patients is eligible to participate in this substudy, which will be ongoing in 2024.
ABCSG 48 / POSITIVE
A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE)
ABCSG 49 / 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 (more…)
ABCSG 50 / BRCA-P
A randomized, double-blind, placebo-controlled, multi-center international phase III study to determine the preventive effect of Denosumab on breast cancer in women carrying a BRCA1 germline mutation (more…)
ABCSG 51 / AURORA
Aiming to understand the molecular aberrations in metastatic breast cancer: The AURORA program (more…)
ABCSG 56 / SASCIA
The ABCSG 56 / SASCIA is a GBG-sponsored, randomized, open-label, postneoadjuvant Phase III study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate, in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment.
ABCSG C08 / EXERCISE
A randomized, phase III trial of endurance exercise following adjuvant chemotherapy for colorectal cancer (more…)
ABCSG P02
A prospective randomized phase II trial of FOLFIRINOX alone versus FOLFIRINOX followed by radiochemotherapy in patients with locally advanced, primarily inoperable pancreatic cancer
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