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New treatment option for Early-stage Breast Cancer
Official title Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)
ClinicalTrials.gov ID: NCT05332561
What this study is testing
What is Atezolizumab 1200 mg in 20 ML Injection?
Atezolizumab 1200 mg in 20 ML Injection is an investigational medicine, being studied as a potential treatment for early-stage breast cancer.
Also referred to as Tecentriq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of written informed consent
- Female and male patients with non-metastatic early (stage I-III) breast cancer aged ≥ 18 years
- Conducted neoadjuvant chemotherapy and surgery as well as conducted standard post-neoadjuvant treatment +/- radiotherapy (standard according to...
- For patients with initially triple negative (TNBC) or HER2-positive breast cancer:
- Non-pCR defined as other than ypT0/is ypN0
You likely can't join if
- Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal...
- Concurrent severe, uncontrolled systemic disease that would place patient at undue risk or interfere with planned treatment
- Concurrent participation or previous treatment within 30 days in another treatment clinical trial
- Persistent toxicity (≥ Grade 2 according to NCI CTCAE v5.0 caused by previous cancer therapy, excluding alopecia
- Clinical signs of active infection (\> Grade 2 according NCI CTCAE v5.0)
- History of or newly diagnosed human immunodeficiency virus (HIV) infection and immunocompromised patients
See the full eligibility criteria
Who can join
- Provision of written informed consent
- Female and male patients with non-metastatic early (stage I-III) breast cancer aged ≥ 18 years
- Conducted neoadjuvant chemotherapy and surgery as well as conducted standard post-neoadjuvant treatment +/- radiotherapy (standard according to German guidelines except Abemaciclib and Olaparib)
- For patients with initially triple negative (TNBC) or HER2-positive breast cancer:
- Non-pCR defined as other than ypT0/is ypN0
- For patients with initially hormone receptor positive and HER2-negative breast cancer: Non-pCR and CPS-EG score
- ≥ 3 and ypN0, or
- ≥ 2 and ypN+
- ECOG Performance Status ≤ 1
- Acute effects of any prior therapy resolved to baseline severity or National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade ≤ 1 except for adverse effects not...
- Postmenopausal or evidence of non-childbearing status. For women of childbearing potential negative urine pregnancy test at post-operative screening and baseline as well as highly effective forms of contraception have...
- Evidence of childbearing potential is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile
- Postmenopausal or evidence of non-childbearing status is defined as:
- Amenorrhea for 1 year or more without an alternative medical cause following cessation of exogenous hormonal treatments plus follicle stimulating hormone (FSH) levels in the postmenopausal range in women not using...
- Chemotherapy-induced menopause
- Surgical sterilisation (bilateral oophorectomy, bilateral salpingectomy, total hysterectomy or tubal ligation at least 6 weeks before IMP treatment)
- Female patients with age ≥ 60 years
- A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
- Female patients of childbearing potential and male patients with partners of childbearing potential who are sexually active must agree to the use of two forms of contraception in combination (male condom and one highly...
- Ability of patient to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations
- Adequate bone marrow, renal, and hepatic function defined by laboratory tests\ The biomarker-guided eligibility for the respective study arm is evaluated and determined exclusively by the NCT molecular tumor board on...
- Arm 1 (Atezolizumab, Immune Evasion ): PD-L1 positivity measure by IHC (≥1% on immune cells within the tumor), MSI-high status (validated by PCR), TMB-H (≥10mut/MB), CD274 amplification
- Arm 2 (Inavolisib, PI3K): Known/reported oncogenic mutation in PIK3Ca
- Arm 3 (Ipatasertib, AKT): Aberrations predicting increased PI3K-AKT pathway activity except PI3K-mutations, HR positive histology
- Arm 4 (Olaparib, PARP, DNA-Repair): Inactivating somatic or germline BRCA1/2 mutation including homozygous deletions, Inactivating germline PALB2 mutations
- Arm 5 (Sacituzumab Govitecan, TROP-2): Trop-2-overexpression (with IHC and except known/reported homozygous polymorphism in UGT1A1\ 28)
- Arm 6 (Trastuzumab / Pertuzumab, ERBBB): HER2 exon-20 insertion, Activating HER2-mutation
What rules you out
- Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1 grade 1 endometrial carcinoma, or...
- Concurrent severe, uncontrolled systemic disease that would place patient at undue risk or interfere with planned treatment
- Concurrent participation or previous treatment within 30 days in another treatment clinical trial
- Persistent toxicity (≥ Grade 2 according to NCI CTCAE v5.0 caused by previous cancer therapy, excluding alopecia
- Clinical signs of active infection (\> Grade 2 according NCI CTCAE v5.0)
- History of or newly diagnosed human immunodeficiency virus (HIV) infection and immunocompromised patients
- Active Hepatitis A virus infection
- Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive...
- Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA
- Dementia or significant impairment of cognitive state
- Epilepsy requiring pharmacologic treatment
- Pregnancy and breast feeding
- Inability to take oral medication and gastrointestinal disorders likely to interfere with absorption of study medication
- Major surgery (any invasive operative procedure in which a more extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered) within four weeks before screening and...
- Systemic chemotherapy or radiotherapy within four weeks or a longer period depending on the characteristics of the agents used
- Heart failure classified as New York Heart Association (NYHA) II/III/IV
- Severe obstructive or restrictive ventilation disorder
- Patients with clinically active tuberculosis
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug
- Is taking or requiring the continued use of any of the prohibited concomitant medications listed in the respective subprotocols at baseline
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3...
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
- Tübingen, Baden-Wurttemberg, Germany
- Augsburg, Bavaria, Germany
- Erlangen, Bavaria, Germany
- Ulm, Bavaria, Germany
- Würzburg, Bavaria, Germany
- Dresden, Saxony, Germany
- Berlin, Germany
- Essen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany; Tübingen, Baden-Wurttemberg, Germany; Augsburg, Bavaria, Germany; Erlangen, Bavaria, Germany; Ulm, Bavaria, Germany; Würzburg, Bavaria, Germany and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.