sophia monarcher detect v detect iii...2017/07/25 · • prior treatment with any cdk 4 and cdk 6...

Marienkrankenhaus Hamburg, Studien des Brustzentrums

Leiterin des Brustzentrums: Dr. med. M. Banys-Paluchowski Tel. 0 40 / 2546 1603, [email protected]

Leiterin des Studiensekretariats: Frau B. Bergel, Tel. 0 40 / 2546 2114

MammaCa M0

MammaCa M1

HR-pos HER2-neg

DETECT IV

Hirnmetastasen BrainMet-Studie

Männliches MammaCa

MammaCa in der Schwangerschaft oder bis 1 J. nach

Geburt

BCP-Studie

Registerstudie Mann

Triple-negativ

HER2-pos DETECT V

KEYNOTE-355

DESIREE

DETECT III

MonarchE

MonarcHER

SOPHIA

HR-pos HER2-neg, N1

HR-pos

CANCER-ID immer möglich

neoadjuvant RESPONDER

Ubersicht Studien - Maggie 2017-07-25.pptx




SOPHIA

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs. Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received

≤ Three Prior Anti-HER2 Therapies and Require Systemic Treatment

Inclusion criteria

• Prior treatment with pertuzumab, trastuzumab, and ado-

trastuzumab emtansine in the neoadjuvant, adjuvant, or

metastatic setting (prior radiotherapy and hormonal

therapies are allowed)

• At least one, and no more than three , lines of therapy in

the metastatic setting. Prior neo-adjuvant or adjuvant

therapy that resulted in relapse within 6 months of the

completion of therapy will be considered a line of

treatment for metastatic disease.

• ECOG 0-1

• HER2-positive on last biopsy

Exclusion criteria

• Known, untreated brain metastasis

• Uncontrolled seizures

• Active hepatitis B or hepatitis C infection




MonarcHER

A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to Standard-of-Care Chemotherapy of Physician’s Choice plus Trastuzumab in Women with HR+, HER2+ Locally Advanced or Metastatic

Breast Cancer

Inclusion criteria

• HR+, HER2+ (> 1 % ER or PR) • Unresectable locally advanced recurrent breast cancer or

metastatic breast cancer • at least 2 HER2-directed therapies for advanced disease

(dual HER2 blockade is considered as 1 prior HER2-directed therapy)

• must have received T-DM1 and a taxane in any setting • Premenopausal patients must receive GnRH > 4 weeks

before start of study • ECOG 0-1, EF ≥ 50%

Exclusion criteria

• Known central nervous system metastases that are

untreated, symptomatic, or require steroids to control symptoms

• Prior treatment with any CDK 4 and CDK 6 inhibitor • Prior fulvestrant




DETECT V / CHEVENDO

A multicenter, randomized phase III study to compare chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta®

(pertuzumab) in patients with HER2 positive and hormone-receptor positive metastatic breast cancer.




DETECT IV

A multicenter phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs).

DETECT IV A / Everolimus: • Disease progression

following prior treatment with endocrine therapy

• Postmenopausal • ≤ 2 prior lines of

chemotherapy

DETECT IV B / Eribulin:

• ≤ 3 prior lines of chemotherapy




A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy vs. Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk,

Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

MonarchE




DESIREE

A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer

Einschlusskriterien: • Histologisch gesicherter Hormonrezeptor-positiver (HR+), HER2-negativer Brustkrebs • Lokal fortgeschritten oder metastasiert und nicht kurativ durch Operation oder Radiotherapie

alleine behandelbar. • Fortschreiten der Erkrankung wahrend oder nach vorheriger Letrozol oder Anastrozol Zwei Arme: 1. Everolimus 10 mg/Tag, oral, Woche 1-3: 4X2,5mg Tag (verblinded); Woche 4-24: 10mg/Tag

(open-label entsprechend Fachinformation)

2. Eine vorgeschaltete Dosiseskalation von Everolimus-Plazebo wie folgt: Woche 1 1x2,5mg Verum + 3x Plazebo/Tag; Woche 2: 2x 2,5mg Verum +2x Plazebo/Tag; Woche 3: 3x 2,5 mg Verum + 1x Plazebo/Tag; Woche 4-24: 10mg/Tag (open-label entsprechend Fachinformation)




RESPONDER

RESPONDER Trial - Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy after Neoadjuvant Chemotherapy in Breast Cancer

Einschlusskriterien

• Abgeschlossene neoadjuvante

Chemotherapie

• Resttumor oder Clip sonographisch

eindeutig darstellbar

• Partielle oder komplette Remission

• Bei Multifokalität müssen mindestens

zwei Läsionen gestanzt sein oder gleiche

Tumorbiologie haben

• M0

Ausschlusskriterien

• cT4

• Dislokation des Clips bei

Komplettremission (> 5 mm)

• Chemotherapie nicht vollständig erhalten

(z.B. unterbrochen bei NW)

https://www.google.de/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiQ3uHpro_UAhUEaVAKHT__BtMQjRwIBw&url=https://www.klinikum.uni-heidelberg.de/Siegel-Wortmarke.8664.0.html&psig=AFQjCNHwUmhwlSboiCsJC6MW1j9oYTMHSQ&ust=1495950176296622




DETECT III

A multicenter, randomized, phase III study to compare standard therapy alone versus standard therapy plus Lapatinib in patients with initially HER2-negative metastatic breast cancer and

HER2-positive circulating tumor cells

Inclusion criteria • Metastatic breast

cancer which cannot be treated by surgery or radiotherapy only

• All biopsies HER2 neg • Evidence of HER2-

positive CTCs




KEYNOTE 355

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or

Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

Possible chemotherapy regimens: 1) nab-paclitaxel

2) paclitaxel 3) gemcitabine/carboplatin

Inclusion criteria • Metastatic breast cancer not previously treated

with chemotherapy or locally recurrent inoperable breast cancer not previously treated with chemotherapy (adjuvant chemotherapy possible)

• ECOG 0 or 1 • Triple-negative

Exclusion criteria • active central nervous system (CNS) metastases

and/or carcinomatous meningitis • history of (non-infectious) pneumonitis that

required steroids or current pneumonitis • interstitial lung disease • history of active tuberculosis (TB) • active infection requiring systemic therapy • history of class II-IV congestive heart failure or

myocardial infarction within 6 months of randomization




CANCER-ID

• EU-Projekt • Untersuchung von zirkulierenden Tumorzellen (CTCs) und zirkulierendem DNA im Blut • Blutentnahme zu Beginn der neuen Therapielinie, danach alle 12 Wochen • 1 CellSearch-Röhrchen, 2 große EDTA




REGISTERSTUDIE MAMMAKARZINOM DES MANNES

Ansprechpartner und Registrierung: Projektleiter: Prof. Dr. med. Dr. h.c. Serban Dan Costa, Dr. med. Holm Eggemann Universitätsfrauenklink Magdeburg Brustzentrum Gerhart Hauptmann Str.35 39108 Magdeburg Koordinator: Dr. med. Holm Eggemann Studiensekretärin: Bianka Klebe Tel. 0391/6717302 FAX 0391/6717483




Brain Metastases in Breast Cancer Network Germany (BMBC, GBG 79): Multicentric, retro- and prospective collection of patient data and biomaterial from breast cancer patients

with brain metastases

sophia monarcher detect v detect iii...2017/07/25 · • prior treatment with any cdk 4 and cdk 6...

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