Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow

NCT00248703 | Completed Phase 2 DMC

• 3 other identifiers: NBCG9S-03032S-03-01434
• Study Type: interventional
• Target: 1,128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify patients with persisting tumor cells after standard epirubicin-containing treatment to test a non-cross resistant chemotherapy regimen (docetaxel) for these patients, and to explore the analysis of disseminated tumor cells in bone marrow as a surrogate marker for clinical outcome.

Conditions

Breast Cancer

Keywords

Disseminating tumor cells,breast cancer,docetaxel,adjuvant

Outcome Measures

Primary Outcomes (1)

• Disease free survival related to presence or absence of disseminated tumor cells

  At approximately 8 years maximum FU

Secondary Outcomes (2)

• Predictive value of primary tumor markers on effects of docetaxel

  At approximately 8 years maximum FU

• Explore markers on tumor cells in bone marrow that can predict the effect of docetaxel

  At approximately of 8 years maximum FU

Study Arms (1)

Docetaxel

EXPERIMENTAL

Patients with presence of disseminated tumor cells in bone marrow after (no-taxane) epirubicin-containing adjuvant treatment receive 6 cycles of docetaxel (100 mg/m2) 3 qw.

Drug: Docetaxel

Interventions

Docetaxel DRUG

Docetaxel 100 mg/m2 3 qw x 6

Also known as: Taxotere

Docetaxel

Eligibility Criteria

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

You may qualify if:

• Breast cancer with node positive disease or high risk node negative disease (pT1c/T2GII-IIIN0, pT3N0, cT3N0). Patients \< 35 years with pT1a-bN0G2-3.
• Primary surgery for breast cancer completed
• Completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing anthracycline
• Age ≥ 18 and \< 70 years
• Eastern Cooperative Oncology Group or WHO performance status \< 2
• Written informed consent prior to beginning protocol specific procedures
• Laboratory requirements (within 5 weeks prior to end of radiation treatment or within 5 weeks prior to completion of baseline examinations):
• Neutrophils ≥ 1.1 10\^9/l, Platelets ≥ 100 10\^9/l, Hemoglobin ≥ 10 g/dl, ASAT and ALAT ≤ x 2.5 UNL (If ALP \> 2.5 ≤ x 5 UNL, then ASAT and ALAT ≤ x 1.5 UNL), ALP ≤ x 5 UNL (If ASAT and ALAT \> 1.5 ≤ x 2.5 UNL, then ALP ≤ 2.5 x UNL), Creatinine ≤ 175 umol/l
• Completed staging analysis including chest X-ray, bone scintigraphy or MRI, liver ultrasound or liver CT scan

You may not qualify if:

• Other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer
• M1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.
• Earlier treatment with paclitaxel or docetaxel.
• Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria (see appendix II)
• Cardiac disease with symptoms classified as NYHA ≥ 2
• Definite contraindications for the use of corticosteroids
• Concurrent treatment with other experimental drugs
• Concurrent treatment with any other anti-cancer therapy (except for endocrine therapy and trastuzumab)
• Pregnancy

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Tromso: collaborator
• Helse Stavanger HF: collaborator
• Sorlandet Hospital HF: collaborator
• Sykehuset Innlandet HF: collaborator
• Ullevaal University Hospital: collaborator
• Sykehuset i Vestfold HF: collaborator
• Sykehuset Ostfold: collaborator
• Alesund Hospital: collaborator

Study Sites (1)

RRHF

Oslo, 0027, Norway

Location

Related Publications (3)

• Naume B, Synnestvedt M, Falk RS, Wiedswang G, Weyde K, Risberg T, Kersten C, Mjaaland I, Vindi L, Sommer HH, Saetersdal AB, Rypdal MC, Bendigtsen Schirmer C, Wist EA, Borgen E. Clinical outcome with correlation to disseminated tumor cell (DTC) status after DTC-guided secondary adjuvant treatment with docetaxel in early breast cancer. J Clin Oncol. 2014 Dec 1;32(34):3848-57. doi: 10.1200/JCO.2014.56.9327. Epub 2014 Nov 3.

  PMID: 25366688 DERIVED

• Gilje B, Nordgard O, Tjensvoll K, Borgen E, Synnestvedt M, Smaaland R, Naume B. Comparison of molecular and immunocytochemical methods for detection of disseminated tumor cells in bone marrow from early breast cancer patients. BMC Cancer. 2014 Jul 15;14:514. doi: 10.1186/1471-2407-14-514.

  PMID: 25023626 DERIVED

• Synnestvedt M, Borgen E, Wist E, Wiedswang G, Weyde K, Risberg T, Kersten C, Mjaaland I, Vindi L, Schirmer C, Nesland JM, Naume B. Disseminated tumor cells as selection marker and monitoring tool for secondary adjuvant treatment in early breast cancer. Descriptive results from an intervention study. BMC Cancer. 2012 Dec 22;12:616. doi: 10.1186/1471-2407-12-616.

  PMID: 23259667 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Bjørn Naume, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: October 1, 2003
• Primary Completion: November 1, 2012
• Study Completion: April 1, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

NO (1)