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

NCT02307227 | Completed Phase 2 DMC

• 1 other identifier: CRO-18-2006
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR)

  pCR was defined as no evidence of microscopic residual invasive cancer, both in breast and ipsilateral axillary lymph nodes, or residual carcinoma in situ in the absence of invasive breast cancer

  60 months

Secondary Outcomes (4)

• Progression free survival

  60 months

• Overall survival

  60 months

• Cardiac safety

  60 months

• Host immune response

  60 months

Study Arms (2)

Locally advanced HER2+ breast cancer pts

EXPERIMENTAL

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

Drug: Trastuzumab; Drug: Paclitaxel

Locally advanced HER2- breast cancer pts

EXPERIMENTAL

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.

Drug: Epirubicin; Drug: Docetaxel

Interventions

Trastuzumab DRUG

Locally advanced HER2+ breast cancer pts

Paclitaxel DRUG

Locally advanced HER2+ breast cancer pts

Epirubicin DRUG

Locally advanced HER2- breast cancer pts

Docetaxel DRUG

Locally advanced HER2- breast cancer pts

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location

Related Publications (4)

• Muraro 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 BACKGROUND

• Muraro 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 DERIVED

• Muraro 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 DERIVED

• Miolo 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Paclitaxel; Epirubicin; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Riccardo Dolcetti, MD

  Centro di Riferimento Oncologico - Aviano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: April 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

IT (1)