Clinical trial · Interventional

Phase II Study With Trastuzumab + Paclitaxel in Locally Advanced HER2+ Tumors or Epirubicin + Taxotere in HER2- Tumors

Antitumor Immune Responses in Breast Cancer Patients Treated With Neoadjuvant Chemotherapy: a Phase II Study With Trastuzumab and Concomitant Weekly Paclitaxel in Patients With HER2+ Tumors or Epirubicin + Taxotere in HER2- Tumors.

NCT02307227CI-TRIAL-00016248completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Prospective, monoinstitutional, phase II study. Patients with HER 2 positive locally advanced breast cancer will be treated with 3 initial cycles (12 weeks) of trastuzumab plus paclitaxel and then if responding further 12 weeks and then with surgical resection, patients with HER2 negative breast carcinoma will be treated with 4 cycles (12 weeks) of epirubicin and taxotere. If responding 4 more cycles (12 weeks). Patients progressing will be treated depending on physician's and patient's preference

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Neoplasms	Breast Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Docetaxel	Drug	Docetaxel	ALIAS
Epirubicin	Drug	Epirubicin	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Trastuzumab	Drug	Trastuzumab	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Locally advanced HER2+ breast cancer pts
description
HER2 positive (defined as 3+ at Herceptest or FISH/CISH positive): treatment with Trastuzumab 4mg/kg first time, then 2 mg/kg weekly with concomitant paclitaxel 80 mg/mq weekly (one cycle corresponding to 4 weeks) for 12 weeks (3 cycles). Clinical and instrumental evaluation, in responding patients continue for additional 12 weeks (total 6 cycles), then surgical excision
interventionNames
1. Drug: Trastuzumab
2. Drug: Paclitaxel
type
EXPERIMENTAL
label
Locally advanced HER2- breast cancer pts
description
HER2 negative: treatment with Epirubicin 90 mg/mq and docetaxel 75 mg/mq every 3 weeks for 4 cycles. Clinical and instrumental evaluation, in responding patients continue for additional 12 weeks (total 8 cycles), then surgical excision.
interventionNames
1. Drug: Epirubicin
2. Drug: Docetaxel

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically proven breast carcinoma evaluated for HER 2 status and immune status
* Locally advanced carcinoma (UICC stage II-III)
* Age \< 70 years
* measurable lesions
* ECOG Performance Status 0-2
* Life expectancy \> 3 months
* Adequate bone marrow and hepatic functions
* Creatinine Clearance \> 40 ml/min
* Written informed consent
* Patients must be accessible for treatment and follow up.

Exclusion Criteria:

* Prior chemotherapy or hormonal treatments
* Brain metastases.
* Past or current history of neoplasm other than curatively treated.
* Concurrent treatment with other experimental drugs.
* Left Ventricular Ejection Fraction (LVEF) \<50 %
* History of significant neurological or psychiatric disorders.

References

Publications (4)

BACKGROUNDMuraro E, Martorelli D, Turchet E, Miolo G, Scalone S, Comaro E, Talamini R, Mastorci K, Lombardi D, Perin T, Carbone A, Veronesi A, Crivellari D, Dolcetti R. A different immunologic profile characterizes patients with HER-2-overexpressing and HER-2-negative locally advanced breast cancer: implications for immune-based therapies. Breast Cancer Res. 2011;13(6):R117. doi: 10.1186/bcr3060. PMID 22112244
DERIVEDMuraro E, De Zorzi M, Miolo G, Lombardi D, Scalone S, Spazzapan S, Massarut S, Perin T, Dolcetti R, Steffan A, De Re V. KIR-HLA Functional Repertoire Influences Trastuzumab Efficiency in Patients With HER2-Positive Breast Cancer. Front Immunol. 2022 Jan 12;12:791958. doi: 10.3389/fimmu.2021.791958. eCollection 2021. PMID 35095867
DERIVEDMuraro E, Comaro E, Talamini R, Turchet E, Miolo G, Scalone S, Militello L, Lombardi D, Spazzapan S, Perin T, Massarut S, Crivellari D, Dolcetti R, Martorelli D. Improved Natural Killer cell activity and retained anti-tumor CD8(+) T cell responses contribute to the induction of a pathological complete response in HER2-positive breast cancer patients undergoing neoadjuvant chemotherapy. J Transl Med. 2015 Jun 27;13:204. doi: 10.1186/s12967-015-0567-0. PMID 26116238
DERIVEDMiolo G, Muraro E, Martorelli D, Lombardi D, Scalone S, Spazzapan S, Massarut S, Perin T, Viel E, Comaro E, Talamini R, Bidoli E, Turchet E, Crivellari D, Dolcetti R. Anthracycline-free neoadjuvant therapy induces pathological complete responses by exploiting immune proficiency in HER2+ breast cancer patients. BMC Cancer. 2014 Dec 15;14:954. doi: 10.1186/1471-2407-14-954. PMID 25512030

Registry

Dates and enrollment

Start: Apr 1, 2006
Primary completion: Apr 1, 2009
Completion: Apr 1, 2014
First posted: Dec 4, 2014
Last update posted: Dec 4, 2014
Enrollment: 46 (actual)
Lead sponsor: Centro di Riferimento Oncologico - Aviano OTHER

Data updated 22 days agoSource updated Dec 4, 2014source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Italy	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.