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

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00248703
• Collaborator: University of Tromso (Other), Helse Stavanger HF (Other), Sorlandet Hospital HF (Other), Sykehuset Innlandet HF (Other), Ullevaal University Hospital (Other), Sykehuset i Vestfold HF (Other), Sykehuset Ostfold (Other), Alesund Hospital (Other)
• Enrollment: 1,128
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 230
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Docetaxel	Phase 2

Detailed Description

The presence of disseminating (or isolated) tumor cells (DTC/ITC) in bone marrow (BM) after completion of adjuvant chemotherapy for breast cancer is associated with poor prognosis. Methods for detection of DTC have potential as a tool for monitoring occult residual disease during follow up. Also, there exists potent chemotherapy proven to be effective when anthracycline-based chemotherapy fails (f.ex. docetaxel). Consequently, a study has been started to test DTC detection as a surrogate marker for clinical outcome in localized breast cancer patients, selected by the presence of DTC in BM after standard adjuvant chemotherapy, receiving secondary treatment with docetaxel. In brief, patients having received anthracycline-containing chemotherapy for localized breast cancer are candidates. After informed consent and no radiologic signs of distant metastasis, the first BM aspiration is performed at the end of radiotherapy or 8-12 weeks after the last chemotherapy cycle. The next BM aspiration is performed 6 months later. At that time point the BMs are analyzed for the presence of DTC. If DTC are present in the 6 months BM test (the first BM sample is for exploratory research purposes), 6 cycles of docetaxel are administered (3qw), followed by a third and forth BM analysis 1 month and 13 months after the end of chemotherapy. The patients receiving docetaxel with eradication of the DTC will be clinically compared to those with persistence of DTC after docetaxel treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1128 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Secondary Adjuvant (Rescue) Treatment With Docetaxel (Taxotere) and Detection of Isolated Tumor Cells in Bone Marrow as a Surrogate Marker for Effect in Node Positive and High Risk Node Negative Breast Cancer After Standard Adjuvant Epirubicin-containing Treatment
• Actual Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Nov 1, 2012
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Docetaxel 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; Docetaxel 100 mg/m2 3 qw x 6; Other Names: Taxotere

Outcome Measures

Primary Outcome Measures

1. Disease free survival related to presence or absence of disseminated tumor cells [At approximately 8 years maximum FU]

Secondary Outcome Measures

1. Predictive value of primary tumor markers on effects of docetaxel [At approximately 8 years maximum FU]

2. Explore markers on tumor cells in bone marrow that can predict the effect of docetaxel [At approximately of 8 years maximum FU]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Breast cancer with node positive disease or high risk node negative disease (pT1c/T2GII-IIIN0, pT3N0, cT3N0). Patients < 35 years with pT1a-bN0G2-3.

2. Primary surgery for breast cancer completed

3. Completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing anthracycline

4. Age ≥ 18 and < 70 years

5. Eastern Cooperative Oncology Group or WHO performance status < 2

6. Written informed consent prior to beginning protocol specific procedures

7. 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

1. Completed staging analysis including chest X-ray, bone scintigraphy or MRI, liver ultrasound or liver CT scan

Exclusion Criteria:

1. Other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer

2. M1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.

3. Earlier treatment with paclitaxel or docetaxel.

4. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria (see appendix II)

5. Cardiac disease with symptoms classified as NYHA ≥ 2

6. Definite contraindications for the use of corticosteroids

7. Concurrent treatment with other experimental drugs

8. Concurrent treatment with any other anti-cancer therapy (except for endocrine therapy and trastuzumab)

9. Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RRHF	Oslo		Norway	0027

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Bjørn Naume, MD, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bjørn Naume, Principal investigator, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT00248703
• Other Study ID Numbers: NBCG9; S-03032; S-03-01434
• First Posted: Nov 4, 2005
• Last Update Posted: Mar 8, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Bjørn Naume, Principal investigator, Oslo University Hospital: Disseminating tumor cells,breast cancer,docetaxel,adjuvant
• Additional relevant MeSH terms: Breast Neoplasms; Docetaxel

Study Results

No Results Posted as of Mar 8, 2021