Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer

Conditions

Breast cancer Cancer Breast

Robert K. Hills, Rosie Bradley, Jeremy Braybrooke, Richard Gray, Hannah Taylor et al. (21 authors)

Journal of Clinical Oncology2023-06-0112 citations

10.1200/jco.2023.41.16_suppl.508

Prognostic impact of CD4-positive T cell subsets in early breast cancer: a study based on the FinHer trial patient population.

Schmidt M, Weyer-Elberich V, Hengstler JG, Heimes AS, Almstedt K, Gerhold-Ay A, Lebrecht A, Battista MJ, Hasenburg A, Sahin U, Kalogeras KT, Kellokumpu-Lehtinen PL, Fountzilas G, Wirtz RM, Joensuu H.

2018-02-2667 citations

10.1186/s13058-018-0942-x

Very high quantitative tumor HER2 content and outcome in early breast cancer.

Joensuu H, Sperinde J, Leinonen M, Huang W, Weidler J, Bono P, Kataja V, Kokko R, Turpeenniemi-Hujanen T, Jyrkkiö S, Isola J, Kellokumpu-Lehtinen PL, Paquet A, Lie Y, Bates M.

2011-02-0121 citations

10.1093/annonc/mdq710

Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer.

Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkiö S, Flander M, Helle L, Ingalsuo S, Johansson K, Jääskeläinen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J, FinHer Study Investigators.

2006-02-01926 citations

10.1056/nejmoa053028

Interventions

Randomisation: 1. Between weekly vinorelbine 25 mg/m^2 x 8 followed by cyclophosphamide, epirubicin and 5-fluorouracil (CEF) x 3 vs three weekly docetaxel 100 mg/m^2 x 3 followed by CE

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed breast cancer 2. Age 65 or less 3. Progesterone receptor (PgR) and human epidermal growth factor receptor two (HER2) status available 4. M0 5. Written informed consent 6. Estimated risk of breast cancer recurrence more than 25% within the first five years from the diagnosis: pN+ or pN0 with tumor size more than 20 mm and PgR negative

Exclusion criteria

Exclusion criteria: 1. Special type of histology without axillary lymph node metastases 2. World Health Organisation (WHO) performance status (PS) more than one 3. Blood leukocyte count less than 3.0 or granulocyte count less than 1.5, thrombocyte count less than 120 4. Severe cardiac disease or hypertension 5. Severe liver disease 6. Pregnancy 7. Male breast cancer 8. More than 12 weeks between breast surgery and study entry 9. Prior cancer except for basalioma/any in situ cancer

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—

Secondary

Measure	Time frame
Survival, safety, quality of life, cardiac ejection fraction	—

Countries

Finland

Outcome results

None listed