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NCT00227656
Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma
Phase 2 trial testing PEG-interferon alfa-2a in Breast Cancer in 2 participants. Terminated before completion.
1 November 2006
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 1 September 2005 |
| Primary completion | 1 November 2006 |
| Estimated completion | 1 November 2006 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- PEG-interferon alfa-2a
- Capecitabine (capecitabine) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Metastatic Cancer — all drugs for Metastatic Cancer →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Breast Cancer or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Neurologic progression-free survival rate at 6 months
Time frame: 6 months
Sponsor's own description
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pegylated interferon alfa-2a may interfere with the growth of tumor cells. Giving capecitabine together with pegylated interferon alfa-2a may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with pegylated interferon alfa-2a works in treating patients with recurrent or progressive brain metastases due to breast cancer.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Investigational chemotherapy and novel pharmacokinetic mechanisms for the treatment of breast cancer brain metastases.
Shah N, Mohammad AS, Saralkar P, Sprowls SA, et al · · 2018 · cited 102× · PMID 29604436 · DOI 10.1016/j.phrs.2018.03.021 -
Double-edged effects of interferons on the regulation of cancer-immunity cycle.
Zhang X, Wang S, Zhu Y, Zhang M, et al · · 2021 · cited 54× · PMID 34262796 · DOI 10.1080/2162402x.2021.1929005 -
Targeting Innate Immunity in Breast Cancer Therapy: A Narrative Review.
Ye Y, Xu C, Chen F, Liu Q, et al · · 2021 · cited 19× · PMID 34899721 · DOI 10.3389/fimmu.2021.771201 -
Immune therapy for breast cancer in 2010-hype or hope?
Florescu A, Amir E, Bouganim N, Clemons M. · · 2011 · cited 19× · PMID 21331271 · DOI 10.3747/co.v18i1.623 -
Harnessing nanomedicine for enhanced immunotherapy for breast cancer brain metastases.
Carney CP, Pandey N, Kapur A, Woodworth GF, et al · · 2021 · cited 15× · PMID 34716900 · DOI 10.1007/s13346-021-01039-9 -
Multidisciplinary management strategies for recurrent brain metastasis after prior radiotherapy: An overview.
Kotecha R, La Rosa A, Brown PD, Vogelbaum MA, et al · · 2025 · cited 6× · PMID 39495010 · DOI 10.1093/neuonc/noae220
Verify or expand the search:
- PubMed search for NCT00227656
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00227656 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 10 December 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00227656.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing