Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Capecitabine for Metastatic Breast Cancer

This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.

Official registry: https://clinicaltrials.gov/study/NCT03424005 · Hoffmann-La Roche · enrollment listed as 1,132

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Capecitabine, Atezolizumab, or Ipatasertib. The registry lists allocation as randomized. This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.

They plan to enroll about 1,132 people at 55 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: 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

Primary outcome (registry wording): Objective Response Rate (ORR)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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):
  • 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

Public study contact (from the registry)

Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

55 listed

+ 29 sites outside the US on the same record

Related recruiting trials in this snapshot

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Phase 2: testing Pembrolizumab (Keytruda) for Metastatic Colorectal Cancer

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.

NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT03424005 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03424005?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03424005?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary