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A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

A legfontosabb adatok

Ki végzi
Hoffmann-La Roche
Hol
Glasgow és London (Egyesült Királyság)Mind a 2 helyszín megnézéseMég 8 másik országban, 52 helyszínen
Állapot
Toboroz
Fázis
1/2. fázis
Résztvevők
1132 fő, tervezett
Kezdés
2018. márc. 30.
Várható befejezés
2030. szept. 30.
A vizsgálat típusa
Beavatkozással járó, 23 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Capecitabine
  • Atezolizumab
  • Ipatasertib
  • SGN-LIV1A
  • Bevacizumab
  • Chemotherapy (Gemcitabine + Carboplatin or Eribulin)
  • Selicrelumab
  • Tocilizumab
  • Nab-Paclitaxel
  • Sacituzumab Govitecan
  • Abemaciclib
  • Fulvestrant
  • Ribociclib (Dose #1)
  • Inavolisib (Dose #1)
  • Trastuzumab Deruxtecan
  • Ribociclib (Dose #2)
  • Letrozole
  • Inavolisib (Dose #2)
  • Empagliflozin
  • Palbociclib
  • Metformin
  • Atirmociclib
  • Giredestrant
A regiszteradat frissítve
2026. november 6.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek a mellrákja szétterjedt, vagy műtéttel nem eltávolítható. Több csoport van, például hármasan negatív, hormonreceptor-pozitív és HER2 mellrák.

Életkor
18 év vagy idősebb.
Nem
Minden nem részt vehet.
A betegség stádiuma
Szétterjedt (áttétes) vagy helyileg előrehaladott, műtéttel nem kezelhető mellrák (adenokarcinóma), legalább egy mérhető daganattal.
Korábbi kezelés
A csoporttól függ. Az egyik csoport még nem kapott korábbi gyógyszeres kezelést a szétterjedt hármasan negatív rákra. Egy másik csoportnál a kemoterápia alatt vagy után romlott a betegség, és még nem kapott immunterápiát. Az 1. szakaszban a korábbi immun-ellenőrzőpont-gátló kezelések kizárnak.
Biomarker vagy leletérték
Egyes csoportokhoz PD-L1-pozitív rák, vagy hormonreceptor-pozitív, HER2-negatív rák kell egy vagy több PIK3CA mutációval. Az egyik csoporthoz HER2-pozitív vagy HER2-alacsony rák kell PIK3CA mutációval.

A részvétel fő kizáró okai

  • Az agyba szétterjedt rák, ha tüneteket okoz, kezeletlen vagy romlik
  • Jelenlegi vagy korábbi autoimmun betegség vagy immunhiány
  • Korábbi őssejt- vagy szilárdszerv-átültetés
  • Aktív tuberkulózis, vagy súlyos fertőzés a kezelés előtti 4 héten belül
  • Terhesség vagy szoptatás

A regiszter feltételei, szó szerint

Mind a 31 feltétel megnézéseKevesebb

Ki vehet részt

  • Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):
  • Age >/= 18 years at the time of signing Informed Consent Form
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • Able to comply with the study protocol, in the investigator's judgment
  • Metastatic or inoperable locally advanced adenocarcinoma of the breast
  • Measurable disease (at least one target lesion) according to RECIST v1.1
  • Life expectancy >/= 3 months, as determined by the investigator
  • Tumor accessible for biopsy, unless archival tissue is available
  • Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing
  • Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

Ki nem vehet részt

  • Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
  • Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade </= 1 or better with the exception of alopecia of any grade and Grade </= 2 peripheral neuropathy
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • History of leptomeningeal disease
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Active tuberculosis
  • Significant cardiovascular disease
  • History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
  • Eligibility only for the control arm
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled tumor-related pain
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Helyszínek itt: Egyesült Királyság

Még 8 másik országban, 52 helyszínen

  • Beatson West of Scotland Cancer CentreGlasgow, Egyesült KirályságNo longer taking part
  • Barts Health NHS Trust St Bartholomew's HospitalLondon, Egyesült KirályságNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.

A teljes eredeti leírásKevesebb

The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study:

Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort).

Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naïve cohort).

Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.

Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).

In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.

A vizsgálat 23 csoportja

  • Atezolizumab + Nab-PaclitaxelMár használt kezelés, összehasonlításként

    1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus nab-paclitaxel until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.

    Kezelés: Atezolizumab és Nab-Paclitaxel

  • Atezolizumab + Nab-Paclitaxel + TocilizumabA vizsgált kezelés

    1L PD-L1-positive participants will receive combination treatment with atezolizumab plus nab-paclitaxel and tocilizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed and participant follow-up is complete.

    Kezelés: Atezolizumab, Tocilizumab és Nab-Paclitaxel

  • Atezolizumab + Sacituzumab GovitecanA vizsgált kezelés

    1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus sacituzumab govitecan until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed.

    Kezelés: Atezolizumab és Sacituzumab Govitecan

  • CapecitabineMár használt kezelés, összehasonlításként

    2L CIT-naïve participants will receive capecitabine until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). Participants who progressed on treatment may have the option of receiving atezolizumab along with chemotherapy (chemo) during stage 2, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.

  • Atezolizumab + IpatasertibA vizsgált kezelés

    2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.

    Kezelés: Atezolizumab és Ipatasertib

  • Atezolizumab + SGN-LIV1AA vizsgált kezelés

    2L CIT-naïve participants will receive doublet combination treatment with atezolizumab plus SGNLIV1A until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Patients who experience loss of clinical benefit as determined by the investigator or unacceptable toxicity related to SGN-LIV1A will be given the option of receiving Atezolizumab + chemo during Stage 2, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.

    Kezelés: Atezolizumab és SGN-LIV1A

  • Atezolizumab + Selicrelumab + BevacizumabA vizsgált kezelés

    2L-CIT-naïve participants will receive doublet combination treatment with atezolizumab plus selicrelumab and bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria. Enrollment is closed and participant follow-up is complete.

    Kezelés: Atezolizumab, Bevacizumab és Selicrelumab

  • Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin)A vizsgált kezelés

    2L CIT-naïve participants enrolled in the active comparator arm who experience disease progression per RECIST v1.1 and 2L CIT-naïve participants enrolled in an experimental arm who experience loss of clinical benefit as determined by the investigator may receive doublet combination treatment with atezolizumab plus chemo (gemcitabine + carboplatin or eribulin) until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Enrollment is closed and participant follow-up is complete.

    Kezelés: Atezolizumab és Chemotherapy (Gemcitabine + Carboplatin or Eribulin)

  • Inavolisib (Dose #2) + Abemaciclib + FulvestrantA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus abemaciclib plus fulvestrant until unacceptable toxicity or disease progression determined by the investigator according to RECIST v1.1.

    Kezelés: Abemaciclib, Fulvestrant és Inavolisib (Dose #2)

  • Inavolisib (Dose #2) + Ribociclib (Dose #1) + FulvestrantA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Fulvestrant, Ribociclib (Dose #1) és Inavolisib (Dose #2)

  • Inavolisib (Dose #2) + Ribociclib (Dose #1) + LetrozoleA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Ribociclib (Dose #1), Letrozole és Inavolisib (Dose #2)

  • Inavolisib (Dose #2) + Ribociclib (Dose #2) + FulvestrantA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Fulvestrant, Ribociclib (Dose #2) és Inavolisib (Dose #2)

  • Inavolisib (Dose #2) + Ribociclib (Dose #2) + LetrozoleA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus ribociclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Ribociclib (Dose #2), Letrozole és Inavolisib (Dose #2)

  • Inavolisib (Dose #2) + Abemaciclib + LetrozoleA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Abemaciclib, Letrozole és Inavolisib (Dose #2)

  • Inavolisib (Dose #1) + Trastuzumab DeruxtecanA vizsgált kezelés

    HER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Enrollment is closed.

    Kezelés: Inavolisib (Dose #1) és Trastuzumab Deruxtecan

  • Inavolisib (Dose #2) + Trastuzumab DeruxtecanA vizsgált kezelés

    HER2+/HER2-low participants will receive inavolisib + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Enrollment is closed.

    Kezelés: Trastuzumab Deruxtecan és Inavolisib (Dose #2)

  • Empagliflozin + Inavolisib (Dose #2) + Fulvestrant ± PalbociclibA vizsgált kezelés

    Participants with locally advanced or metastatic, HR+, HER2- participants will receive empagliflozin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Fulvestrant, Inavolisib (Dose #2), Empagliflozin és Palbociclib

  • Metformin + Inavolisib (Dose #2) + Fulvestrant ± PalbociclibA vizsgált kezelés

    Participants with locally advanced or metastatic, HR+, HER2- participants will receive metformin plus inavolisib plus fulvestrant with or without palbociclib until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Fulvestrant, Inavolisib (Dose #2), Palbociclib és Metformin

  • Inavolisib (Dose #2) + Atirmociclib (Atirmo) + FulvestrantA vizsgált kezelés

    Participants will receive inavolisib plus atirmociclib plus fulvestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Fulvestrant, Inavolisib (Dose #2) és Atirmociclib

  • Inavolisib (Dose #1) + Abemaciclib + LetrozoleA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus abemaciclib plus letrozole until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Abemaciclib, Inavolisib (Dose #1) és Letrozole

  • Inavolisib (Dose #1) + Abemaciclib + GiredestrantA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Abemaciclib, Inavolisib (Dose #1) és Giredestrant

  • Inavolisib (Dose #2) + Abemaciclib + GiredestrantA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus abemaciclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Abemaciclib, Inavolisib (Dose #2) és Giredestrant

  • Inavolisib (Dose #2) + Ribociclib (Dose #1) + GiredestrantA vizsgált kezelés

    HR+ participants will receive treatment with inavolisib plus ribociclib plus giredestrant until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

    Kezelés: Ribociclib (Dose #1), Inavolisib (Dose #2) és Giredestrant

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
Hivatalos cím
A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2026. november 6.