NCT01049425 · CITED IN SOURCE DOCUMENTS

Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2019-08-14

The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy. Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria(Screening): * Female patients, age at diagnosis 18 - 75 years * Histological confirmed unilateral primary invasive carcinoma of the breast * Adequate surgical treatment with complete resection of the tumor (R0) and resection of \> or = 10 axillary nodes or SLN in clinically N0 patients * T1 - T4 (if operable, inflammatory breast cancer is excluded) * Her-2 non-over expressing tumor confirmed by IHC/FISH * Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization * Node positive disease or node negative disease with at least one other risk factor (tumor size \> or = 2 cm, grade \> or = 2, ER and PR negative, high uPA//PAI-1 levels) * No evidence for distant metastasis (M0) after conventional staging * Performance Status ECOG \< or = 1 or KI \> or = 80 % * The patient must be accessible for treatment and follow-up * Written informed consent for central pathology review and evaluation of Recurrence Score (HR positive) and participation in the planB trial prior to beginning specific protocol procedures HR positive patients: * Patient willingness to participate in adjuvant chemotherapy planB trial if RS \> 11 * Indication for chemotherapy given provided either \> 4 involved lymph nodes or RS \> 11 in 1-3 lymph nodes or N0 disease Additional Inclusion Criteria (Randomisation to chemotherapy): * Laboratory requirements (within 21 days prior to randomization): * Leucocytes \> or = 3.5 109/L * platelets \> or = 100 109/L * haemoglobin \> or = 10 g/dL * total bilirubin \< or = 1 ULN * ASAT (SGOT) and ALAT (SGPT) \< or = 2.5 UNL * creatinine \< 175 ymol/L (2 mg/dL) * Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients * LVEF within normal limits of each institution measured by echocardiography or MUGA scan and Exclusion Criteria(Screening): * HER2 over expression confirmed by IHC/FISH/CISH * Known hypersensitivity reaction to the compounds or incorporated substances * Known polyneuropathy \> or = grade 2 * Severe and relevant comorbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease. * Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri or ipsilateral ductal carcinoma in-situ (DCISpTis of the breast) * Non-operable breast cancer including inflammatory breast cancer * Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry * Male breast cancer * Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less then 1% failure rate) non-hormonal contraceptive measures during the study treatment * Breast feeding woman * Sequential breast cancer * Lack of patient compliance Additional Exclusion Criteria (Randomisation): * Inadequate organ function including: * Leucocytes \< 3,5 G/l * platelets \< 100 G/l * creatinine or bilirubin above normal limits * alkaline phosphatise \> 5 UNL * ASAT and/or ALAT associated with AP \> 2.5 UNL * uncompensated cardiac function * Time since axillary dissection \> 42 days
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
intervention Names
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Docetaxel
label
Epirubicin and Cyclophosphamid followed by Docetaxel
type
ACTIVE_COMPARATOR
description
intravenous infusion on day one every three weeks
intervention Names
Drug: Cyclophosphamide
Drug: Docetaxel
label
Combination of Docetaxel and Cyclophosphamid
type
EXPERIMENTAL

interventions

arm Group Labels
Epirubicin and Cyclophosphamid followed by Docetaxel
description
4 cycles, intravenous use, day 1 every three weeks
name
Epirubicin
type
DRUG
arm Group Labels
Epirubicin and Cyclophosphamid followed by Docetaxel
description
4 cycles, intravenous infusion, day 1 every three weeks
name
Cyclophosphamide
type
DRUG
arm Group Labels
Epirubicin and Cyclophosphamid followed by Docetaxel
description
4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy
name
Docetaxel
type
DRUG
arm Group Labels
Combination of Docetaxel and Cyclophosphamid
description
6 cycles, intravenous infusion, day 1 every 3 weeks
name
Cyclophosphamide
type
DRUG
arm Group Labels
Combination of Docetaxel and Cyclophosphamid
description
6 cycles, intravenous infusion, day one every three weeks
name
Docetaxel
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3198
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment
time Frame
5 years

Full study description

brief Summary: The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy. Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.

Source references

references

citation
Sechi A, Mijnes J, Villwock S, Rose M, Steib F, Bringezu S, Berger J, Schalla C, von Serenyi S, Dietrich J, Ortiz-Bruchle N, Heij L, Bednarsch J, Gluz O, Nitz U, Harbeck N, Graeser M, Zu Eulenburg C, Mohammadian MP, Jozwiak K, Kreipe HH, Christgen M, Radner M, Jonigk D, Dahl E. The Janus Face of SPAG6: Inducing EMT in Luminal Breast Cancer Cells Amidst Widespread Expression Loss in Breast Tumours. J Cell Mol Med. 2025 Oct;29(19):e70870. doi: 10.1111/jcmm.70870.
pmid
41066509
type
DERIVED
citation
Kolberg-Liedtke C, Gluz O, Heinisch F, Feuerhake F, Kreipe H, Clemens M, Nuding B, Malter W, Reimer T, Wuerstlein R, Graeser M, Shak S, Nitz U, Kates R, Christgen M, Harbeck N. Association of TILs with clinical parameters, Recurrence Score(R) results, and prognosis in patients with early HER2-negative breast cancer (BC)-a translational analysis of the prospective WSG PlanB trial. Breast Cancer Res. 2020 May 14;22(1):47. doi: 10.1186/s13058-020-01283-w.
pmid
32408905
type
DERIVED
citation
Nitz U, Gluz O, Clemens M, Malter W, Reimer T, Nuding B, Aktas B, Stefek A, Pollmanns A, Lorenz-Salehi F, Uleer C, Krabisch P, Kuemmel S, Liedtke C, Shak S, Wuerstlein R, Christgen M, Kates RE, Kreipe HH, Harbeck N; West German Study Group PlanB Investigators. West German Study PlanB Trial: Adjuvant Four Cycles of Epirubicin and Cyclophosphamide Plus Docetaxel Versus Six Cycles of Docetaxel and Cyclophosphamide in HER2-Negative Early Breast Cancer. J Clin Oncol. 2019 Apr 1;37(10):799-808. doi: 10.1200/JCO.18.00028. Epub 2019 Feb 20.
pmid
30785826
type
DERIVED
citation
Nitz U, Gluz O, Christgen M, Kates RE, Clemens M, Malter W, Nuding B, Aktas B, Kuemmel S, Reimer T, Stefek A, Lorenz-Salehi F, Krabisch P, Just M, Augustin D, Liedtke C, Chao C, Shak S, Wuerstlein R, Kreipe HH, Harbeck N. Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial. Breast Cancer Res Treat. 2017 Oct;165(3):573-583. doi: 10.1007/s10549-017-4358-6. Epub 2017 Jun 29.
pmid
28664507
type
DERIVED
citation
Gluz O, Nitz UA, Christgen M, Kates RE, Shak S, Clemens M, Kraemer S, Aktas B, Kuemmel S, Reimer T, Kusche M, Heyl V, Lorenz-Salehi F, Just M, Hofmann D, Degenhardt T, Liedtke C, Svedman C, Wuerstlein R, Kreipe HH, Harbeck N. West German Study Group Phase III PlanB Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment. J Clin Oncol. 2016 Jul 10;34(20):2341-9. doi: 10.1200/JCO.2015.63.5383. Epub 2016 Feb 29.
pmid
26926676
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice