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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Alesund Hospital; Helse Stavanger HF; Sorlandet Hospital HF; Sykehuset i Vestfold HF; Sykehuset Innlandet HF; Sykehuset Ostfold; Ullevaal University Hospital; University of Tromso
• Treatments: Docetaxel; Epirubicin

Criteria

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

8. 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