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Approved For Marketing EXPANDED_ACCESS NCT00338247

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer

Sponsor: Novartis

Conditions Neoplasms, Breast
Interventions lapatinib + capecitabine
Updated 10 times since 2017 Last updated: Apr 4, 2016 Started: Jul 31, 2006 Primary completion: Mar 31, 2015 Completion: Mar 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Neoplasms, Breast and is currently ongoing. Novartis leads this study, which shows 10 recorded versions since 2006 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotApproved For Marketing~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshotApproved For Marketing~Jul 2017 – ~Apr 2018 · 9 months · monthly snapshotApproved For Marketing~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotApproved For Marketing~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotApproved For Marketing~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotApproved For Marketing~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotApproved For Marketing~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotApproved For Marketing~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshotApproved For Marketing~Dec 2025 – present · 7 months · monthly snapshotApproved For Marketing

Change History

10 versions recorded

  1. Dec 2025 — Present [monthly]

    Approved For Marketing

  2. Sep 2025 — Dec 2025 [monthly]

    Approved For Marketing

  3. Sep 2024 — Sep 2025 [monthly]

    Approved For Marketing

  4. Jul 2024 — Sep 2024 [monthly]

    Approved For Marketing

  5. Jan 2021 — Jul 2024 [monthly]

    Approved For Marketing

▶ Show 5 earlier versions

  1. Jun 2018 — Jan 2021 [monthly]

    Approved For Marketing

  2. Apr 2018 — Jun 2018 [monthly]

    Approved For Marketing

    Phase: NA → None

  3. Jul 2017 — Apr 2018 [monthly]

    Approved For Marketing NA

    Phase: PHASE4 → NA

  4. Feb 2017 — Jul 2017 [monthly]

    Approved For Marketing PHASE4

  5. Jan 2017 — Feb 2017 [monthly]

    Approved For Marketing PHASE4

    First recorded

Jul 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amersfoort, Netherlands , Amsterdam, Netherlands , Anchorage, United States , Ancona, Italy , Ann Arbor, United States , Arlington, United States , Asheville, United States , Athens, Greece , Augsburg, Germany , Augusta, United States and 379 more locations