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A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) (Keyriched-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988036
Recruitment Status : Unknown
Verified September 2020 by West German Study Group.
Recruitment status was:  Recruiting
First Posted : June 17, 2019
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
NanoString Technologies, Inc.
Information provided by (Responsible Party):
West German Study Group

Brief Summary:
Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pembrolizumab Drug: Trastuzumab Biosimilar ABP 980 Drug: Pertuzumab Phase 2

Detailed Description:

HER2-positive breast cancer is best defined by multiparameter gene expression profiling rather than analysis of the overexpression/amplification status of only HER2. As this subgroup is often correlated with a high expression of TILs and PD/PD-L1, immunogenic therapy strategies seem very promising. The pCR highly correlates with the overall outcome of patients with HER2-positive breast cancer [7]. Therefore, the pCR rate after neoadjuvant treatment has been adopted as a surrogate endpoint and, more recently, as a basis for accelerated drug approval [38].

Due to the high number of patients achieving a pCR after standard treatment of anti-HER2 therapy combined with chemotherapy, de-escalated strategies seem promising and designing a chemotherapy-free trial regimen is therefore modern, justifiable and of high scientific value. Therefore, we designed a prospective phase II, single arm, hypothesis-generating trial investigating the rate of pCR in patients with HER2-enriched breast cancer receiving four cycles of dual anti-HER2 blockade in combination with the checkpoint inhibitor pembrolizumab. Further translational research will be added to gain further insight into the tumor response or resistance to this treatment approach. The addition of standard chemotherapy after this study treatment will be at the discretion of the investigator. In case of a non-pCR after study treatment, continuing treatment with chemotherapy and antihormonal therapy in case of HR positive disease is highly recommended.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open Label, Neoadjuvant Phase II Single Arm Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: HER2-enriched

Trial treatment is defined as neoadjuvant therapy only. The Investigational Medicinal Products (IMPs) are pembrolizumab, trastuzumab biosimilar and pertuzumab.

  • Trastuzumab Biosimilar (Trazimera®) - Investigational Medicinal Product

    • Loading dose: 8 mg/kg bodyweight at initial administration infusion over 90 min; monitor patient for at least 6 h afterwards.
    • Maintenance dose: 6 mg/kg bodyweight, over 30-90 min; monitor patient for 2 h afterwards.
    • Route: Intravenous infusion.
    • Schedule: Every 3 weeks during the neoadjuvant phase.
  • Pertuzumab (Perjeta®) - Investigational Medicinal Product

    • Loading dose: 840 mg, initial administration.
    • Maintenance dose: 420 mg.
    • Route: Intravenous infusion.
    • Schedule: Every 3 weeks during the neoadjuvant phase.
  • Pembrolizumab (Keytruda®) - Investigational Medicinal Product

    • Dose: 200 mg.
    • Route: Intravenous infusion.
    • Schedule: Every 3 weeks during the neoadjuvant phase.
Drug: Pembrolizumab
Intravenous infusion; 200 mg; every 3 weeks
Other Name: Keytruda®

Drug: Trastuzumab Biosimilar ABP 980
Intravenous infusion; 8 mg/kg loading dose, thereafter 6 mg/kg; every 3 weeks
Other Name: Trazimera®

Drug: Pertuzumab
Intravenous infusion; 840 mg/kg loading dose, thereafter 420 mg/kg; every 3 weeks
Other Name: Perjeta®




Primary Outcome Measures :
  1. Evaluation of the pCR rate of the combination therapy consisting of pembrolizumab in combination with the dual anti-HER2 blockade trastuzumab biosimilar ABP 980 and pertuzumab in patients with HER2-enriched early breast cancer assessed by PAM50 testing [ Time Frame: After neoadjuvant treatment (planned duration of treatment is 12 weeks) ]
    pCR defined as no invasive tumor in breast and lymph nodes (ypT0/is, ypN0) at surgery after study treatment


Secondary Outcome Measures :
  1. Number and percentage of fatal adverse events as assessed by CTCAE 5.0 [ Time Frame: 9 months for individual participants ]
    AEs classified by System Organ Class (SOC) and Preferred Terms (PT), descriptive analysis by number of observations and their percentage.

  2. Number and percentage of serious treatment-emergent adverse events as assessed by CTCAE 5.0 [ Time Frame: 9 months for individual participants ]
    AEs classified by System Organ Class (SOC) and Preferred Terms (PT), descriptive analysis by number of observations and their percentage.

  3. Number and percentage of treatment-related adverse events as assessed by CTCAE 5.0 [ Time Frame: 9 months for individual participants ]
    AEs classified by System Organ Class (SOC) and Preferred Terms (PT), descriptive analysis by number of observations and their percentage.

  4. Number and percentage of treatment-emergent adverse events of interest as assessed by CTCAE 5.0 [ Time Frame: 9 months for individual participants ]
    AEs classified by System Organ Class (SOC) and Preferred Terms (PT), descriptive analysis by number of observations and their percentage.

  5. Number and percentage of adverse events leading to investigational product discontinuation [ Time Frame: 9 months for individual participants ]
    AEs classified by System Organ Class (SOC) and Preferred Terms (PT), descriptive analysis by number of observations and their percentage.

  6. Number and percentage of severity of adverse events as assessed by CTCAE 5.0 [ Time Frame: 9 months for individual participants ]
    Descriptive analysis by number of observations and their percentage.

  7. Number and percentage of causality of adverse events as assessed by investigator and sponsor [ Time Frame: 9 months for individual participants ]
    Descriptive analysis by number of observations and their percentage.

  8. Number and percentage of outcome of adverse events as per investigator assessment [ Time Frame: 9 months for individual participants ]
    Descriptive analysis by number of observations and their percentage.

  9. Number and percentage of seriousness of adverse events as assessed by CTCAE 5.0 [ Time Frame: 9 months for individual participants ]
    Descriptive analysis by number of observations and their percentage.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female participants, who are at least 18 years of age on the day of signing informed consent with newly histologically locally confirmed diagnosis of HER2neu 2+ or 3+ breast cancer.
  • Have previously untreated, non-metastatic (M0) HER2-enriched breast cancer defined as the following combined primary tumor (T) and regional lymph node (N) staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 7 as assessed by the Investigator based on radiological and/or clinical assessment:

T1c, N0-N2; T2, N0-N2; T3, N0-N2

  • Patients with HER2-enriched, estrogen and/ or progesterone receptor positive or negative breast cancer defined by American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines can be included.
  • Availability of tumor imaging performed within three months prior to start of screening phase: breast ultrasound and computed tomography (CT) thorax/abdomen or chest X-ray/liver ultrasound, bone scan, mammography or breast magnetic resonance imaging (MRI) (according to local standard).
  • Ability to provide archived tumor tissue sample or at least two newly obtained separate tumor cores from the primary tumor or excisional biopsy of a tumor lesion not previously irradiated at screening to the central laboratory. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred over slides. Newly obtained biopsies are preferred over archived tissue.

Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.

Patients are eligible to be included in the trial only if all of the following criteria apply [items 1-6 must be met by the patient to be enrolled into the trial and before the start of the screening phase]:

  1. Female patients, who are at least 18 years of age on the day of signing informed consent, with newly histologically locally confirmed diagnosis of HER2neu 2+ or 3+ breast cancer.
  2. Previously untreated, non-metastatic (M0) HER2-enriched breast cancer defined as the following combined primary tumor (T) and regional lymph node (N) staging per AJCC for breast cancer staging criteria version 7 as assessed by the investigator based on radiological and/or clinical assessment:

    • T1c, N0-N2;
    • T2, N0-N2;
    • T3, N0-N2.
  3. Patients with HER2-enriched, estrogen and/or progesterone receptor-positive or -negative breast cancer defined by ASCO/CAP guidelines.
  4. Availability of tumor imaging performed within three months prior to start of screening phase: breast ultrasound and CT thorax/abdomen or chest X-ray/liver ultrasound, bone scan, mammography or breast MRI (according to local standard).
  5. Ability to provide an archived tumor tissue sample or at least two newly obtained separate tumor cores from the primary tumor or excisional biopsy of a tumor lesion not previously irradiated at screening to the central laboratory. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred over slides. Newly obtained biopsies are preferred over archived tissue.

    Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.

  6. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and if at least one of the following conditions applies:

    1. not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
    2. a WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 7 months after the last dose of study treatment Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
  7. The patient provides written informed consent for participation in the trial. The patient may also provide consent for future biomedical research. However, the patient may participate in the main trial without participating in future biomedical research.
  8. Confirmed HER2neu (IHC 2+ status and amplification [e.g. by FISH] or IHC 3+ status) tumor identification by local pathology.
  9. Confirmed HER2-enriched status by PAM50 testing.
  10. Confirmed HR+ or HR- status.
  11. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or borderline, a serum pregnancy test will be required.

    Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for the patient to start receiving study medication.

  12. Left ventricular ejection fraction (LVEF) of ≥55% or ≥ institution lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening or performed in clinical routine within 6 weeks prior to first treatment allocation.
  13. Normal ECG performed at screening or performed in clinical routine within 6 weeks prior to first treatment allocation.
  14. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG performance status is to be performed within 10 days prior to the date of treatment initiation.
  15. Adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study treatment.

Exclusion Criteria:

• Patients are excluded from the trial if any of the following criteria apply:

  1. Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g. CTLA-4, OX 40, CD137) or has participated in MK-3475 clinical trials.
  2. Patient has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to first dose of study medication.

    Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy may be eligible.

    Note: If the patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.

  3. Patient has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.
  4. Patient is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.

    Note: Patients who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. Patient should be excluded if she received an investigational agent with anti-cancer or anti-proliferative intent within the last 12 months.

  5. Patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  6. Prior malignancy with a disease-free survival of ≤5 years before signing informed consent.

    Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

  7. Patient has a known hypersensitivity to the components of the study therapy, its analogs, murine proteins or any of the excipients.
  8. Patient has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  9. Patient has a significant cardiovascular disease, such as:

    • LVEF <55%
    • History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the past 6 months
    • Congestive heart failure (CHF) New York Heart Association (NYHA) Class I-IV or history of CHF NYHA class III or IV
  10. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the trial, including but not confined to:

    • Unstable arrhythmias requiring treatment, i.e., atrial tachycardia with a heart rate ≥100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block
    • Angina pectoris within the last 6 months requiring anti-anginal medication
    • Clinically significant valvular heart disease
    • Evidence of myocardial infarction on electrocardiogram (ECG)
    • Poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg).
  11. Inadequate organ function including but not confined to:

    • hepatic impairment (Child Pugh Class C)
    • pulmonary disease (severe dyspnea at rest due to complications of advanced malignancy or requiring oxygen therapy).
  12. Patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  13. Patient has an active infection requiring systemic therapy.
  14. Patient has a known history of human immunodeficiency virus (HIV), hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as detectable HCV RNA [qualitative] is detected).

    Note: Testing of hepatitis B is required in all patients during screening as standard of care according to current guidelines in early breast cancer.

    HIV and hepatitis C testing is required in all patients with significant risk factors (see checklist below). There is a significant risk if one of the items on the checklist applies for the patient.

    • HIV and hepatitis C risk checklist:
    • Patient has frequently changing sexual partners.
    • Patient practices anal sex.
    • The patient has already been diagnosed with another sexually transmitted infection, such as syphilis or gonorrhea.
    • Patient suffers from drug abuse.
    • Tattoos or piercings abroad within the last 4 months.
    • Presence of a positive HIV and/or Hepatitis C test.
    • Patient received a blood transfusion before 1992.
    • Patient is an organ transplant recipient.
    • The patient's mother has/had HIV and/or hepatitis C.
    • Patient has elevated liver blood values (relevant for hepatitis C risk).
  15. Patient has a known history of active TB (Bacillus Tuberculosis).
  16. Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  17. Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  18. Patient is pregnant or breastfeeding, or expecting to conceive children or planning to breastfeed within the projected duration of the trial, starting with the screening visit through 7 months after end of treatment.
  19. Male patients with breast cancer.
  20. History of breast cancer.
  21. Factors indicating risk of poor compliance.
  22. Pathological laboratory assessments:

    • Thrombocytopenia > CTCAE grade 1
    • Increases in ALT/AST > CTCAE grade 1
    • Hypokalemia > CTCAE grade 1
    • Neutropenia > CTCAE grade 1
    • Anemia > CTCAE grade 1
  23. Non-operable breast cancer including inflammatory breast cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988036


Contacts
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Contact: Sherko Kuemmel, Professor +4920117433001 s.kuemmel@kem-med.com
Contact: Marcel Tahlheim +4921615662313 marcel.tahlheim@wsg-online.com

Locations
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Germany
Universitätsklinikum Tübingen Department für Frauengesundheit Not yet recruiting
Tübingen, BaWü, Germany, 72076
Contact: Andreas Hartkopf, Prof. Dr. med.    +49 707-1029822211    andreas.hartkopf@med.uni-tuebingen.de   
Contact: Emily Irslinger    +49 707-01982203    emily.irslinger@med.uni-tuebingen.de   
Principal Investigator: Andreas Hartkopf, Prof. Dr. med.         
Sub-Investigator: Eva-MAria Grischke, Prof. Dr. med.         
Brustzentrum, LMU Klinikum, Ludwig-Maximilians-Universität, Not yet recruiting
Muenchen, Bayern, Germany, 80337
Contact: Nadia Harbeck, Prof. Dr. med.       nadia.harbeck@med.uni-muenchen.de   
Contact: Farangis Stahl    +49-89-440054170    farangis.stahl@med.uni-muenchen.de   
Sub-Investigator: Raquel Würstlein, Dr. med.         
Principal Investigator: Nadia Harbeck, PRof. Dr. med.         
Rotkreuz Klinikum München Not yet recruiting
Muenchen, Bayern, Germany, 80637
Contact: Michael Braun, Prof. Dr. med.    +49 89 130330    michael.braun@swmbrk.de   
Contact: Harry Reisch    +49 89 13033662    harry.reisch@swmbrk.de   
Principal Investigator: Michael Braun, Prof. Dr. med.         
Sub-Investigator: Claus Hanusch, Dr. med.         
"Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Brustzentrum" Not yet recruiting
Frankfurt, Hessen, Germany, 60431
Contact: Marc Thill, Prof. Dr. med.    +49 69 95332228    marc.thill@fdk.info   
Contact: Madeleine Modrow, MSc    +49 69 9533 0    madeleine.modrow@fdk.info   
Principal Investigator: Marc Thill, Prof. Dr. med.         
Sub-Investigator: Christiane Brandi, Dr. med.         
Niels-Stensen-Kliniken Franziskus-Hospital Not yet recruiting
Georgsmarienhütte, Niedersachsen, Germany, 49124
Contact: Kerstin Lüdtke-Heckenkamp, Dr. med.    +49 541 5022466    jost.wamhoff@niels-stensen-kliniken.de   
Contact: Jost Wamhoff, Dr. med.    +49 541 5022466    jost.wamhoff@niels-stensen-kliniken.de   
Principal Investigator: Kerstin Lüdtke-Heckenkamp, Dr. med.         
Sub-Investigator: Jost Wamhoff, Dr. med.         
"Diakovere Henriettenstift Frauenklinik" Not yet recruiting
Hannover, Niedersachsen, Germany, 30559
Contact: Angela Kentsch, Dr. med.    +49 511 2893455    angela.kentsch@diakovere.de   
Contact: Sabine Anolke    +49 511 2893455    sabine.anolke@diakovere.de   
Principal Investigator: Angela Kentsch, Dr. med.         
Sub-Investigator: Anne-Kathrin Gillenberg, Dr. med.         
Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum Recruiting
Essen, NRW, Germany, 45136
Contact: Sherko Kuemmel, Prof. Dr    +49-201-17433005    s.kuemmel@kliniken-essen-mitte.de   
Contact: Dorothea Schindowski    +49-201-17433005    d.schindowski@kliniken-essen-mitte.de   
Principal Investigator: Sherko Kuemmel, Prof. Dr.         
Sub-Investigator: Mattea Reinisch, Dr. med.         
St. Elisabeth Krankenhaus GmbH Not yet recruiting
Koeln, NRW, Germany, 50935
Contact: Gertrud Helling-Giese, Dr. med.         
Sub-Investigator: Susanne Brandner, Dr. med         
Principal Investigator: Gertrud Helling-Giese, Dr. med.         
Praxis für gynäkologische Onkologie am Ev. Krankenhaus Bethesda Not yet recruiting
Moenchengladbach, NRW, Germany, 41061
Contact: Oleg Gluz, PD Dr    +49-2161-9811154    oleg.gluz@brustzentrum-rhein-ruhr.com   
Contact: Kathrin Siebmanns    +49-2161-9813577    kathrin.siebmannsn@brustzentrum-rhein-ruhr.com   
Sub-Investigator: Raquel von Schumann, Dr. med.         
Principal Investigator: Oleg Gluz, PD Dr         
Sub-Investigator: Iris Scheffen, Dr. med.         
Überörtliche Berufsausübungsgemeinschaft Dr. H. Forstbauer, C. Ziske, R. Reihs, E. Rodermann, A. Diel Not yet recruiting
Troisdorf, NRW, Germany, 53840
Contact: Carsten Ziske, PD Dr. med.    +49 2241 3974660    ziske@onkologie-rheinsieg.de   
Contact: Petra Bois@onkologie-rheinsieg.de    +49 2241 397566877    bois@onkologie-rheinsieg.de   
Principal Investigator: Carsten Ziske, PD Dr. med.         
Sub-Investigator: Andreas Diel         
Universitätsklinikum Carl-Gustv-Carus, Klinik für Frauenheilkunde und Geburtshilfe Not yet recruiting
Dresden, Sachsen, Germany, 01307
Contact: Theresa Link, Dr. med.         
Principal Investigator: Theresa Link, Dr. med.         
Sub-Investigator: Pauline Wimberger, Prof. Dr. med.         
Universität Lübeck, Brustzentrum Not yet recruiting
Lübeck, Schleswig-Holstein, Germany, 23562
Contact: Nana Bündgen, Dr. med.    +49 451      
Principal Investigator: Nana Bündgen, Dr. med.         
Sub-Investigator: Henriette Princk, Dr. med.         
Charité - Universitätsmedizin Berlin, CCM; Klinik f. Gynäkologie m. S. Senologie / Brustzentrum Not yet recruiting
Berlin, Germany, 10117
Contact: Jens Blohmer, Prof. Dr.med.    +49 30 450564172    Jens.blohmer@charite.de   
Contact: Joerg Spahrbier    +49 30 450664297    joerg.spahrbier@charite.de   
Principal Investigator: Jens Blohmer, Prof. Dr. med         
Sub-Investigator: Cornelia Kolberg-Liedtke, Prof. Dr. med         
Ev. Waldkrankenhaus Spandau Not yet recruiting
Berlin, Germany, 13589
Contact: Jochem Potenberg, Dr. med.    +49 30      
Principal Investigator: Bjoern Beurer, Dr. med.         
Sub-Investigator: Jochem Potenberg, Dr. med.         
Mammazentrum HH am Krankenhaus Jerusalem Not yet recruiting
Hamburg, Germany, 20357
Contact: Felix Hilpert, Prof. Dr. med.    +49 40 44190671    hilpert@mammazentrum.eu   
Contact: Silke Kassner    +49 40 44190557    kassner@mammazentrum.eu   
Principal Investigator: Felix Hilpert, Prof. Dr. med.         
Sub-Investigator: Christian Schem, Prof. Dr. med.         
Sponsors and Collaborators
West German Study Group
Merck Sharp & Dohme LLC
NanoString Technologies, Inc.
Investigators
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Principal Investigator: s.kuemmel@kem-med.com Kuemmel, Professor Clinics Essen-Mitte, Breast Center
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Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT03988036    
Other Study ID Numbers: WSG-AM09
2018-003996-37 ( EudraCT Number )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by West German Study Group:
HR positive
HER2 negative
Early breast cancer
Neoadjuvant
Anti-HER2 therapy
Pertuzumab
Trastuzumab
Pembrolizumab
Immune checkpoint inhibitor
PD-1
PDL-1
PAM50
Phase 2
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents