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Primary Breast CancerPhase 3planBNCT01049425

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

A Phase 3 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Primary Breast Cancer and Her2 Non-overexpressing, run by Women's Cancer Study Group GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Epirubicin, Cyclophosphamide and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,198 participants
Where
1 siteGermany
Study dates
5 Feb 2009to 15 May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Bethesda Krankenhaus

    Mönchengladbach, 41061

Other trials in Germany

About this study

Official title: Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

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.

Keywords
anthracycline-free, OncotypDX, taxane, Her2 negative breast cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpirubicinDrug

    4 cycles, intravenous use, day 1 every three weeks

  • CyclophosphamideDrug

    4 cycles, intravenous infusion, day 1 every three weeks

  • DocetaxelDrug

    4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy

  • CyclophosphamideDrug

    6 cycles, intravenous infusion, day 1 every 3 weeks

  • DocetaxelDrug

    6 cycles, intravenous infusion, day one every three weeks

Study groups in NCT01049425
Study groupRoleWhat they receive
Epirubicin and Cyclophosphamid followed by DocetaxelActive comparator4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel
Combination of Docetaxel and CyclophosphamidExperimentalintravenous infusion on day one every three weeks
Receives: Drug: Cyclophosphamide; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2010 (estimated)
  2. Study start5 Feb 2009
  3. Primary completion1 Mar 2017
  4. Study completion15 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01049425
Sponsor's protocol ID
WSG AM04
Acronym
planB
Status last verified
Aug 2019
First submitted
12 Jan 2010
Last updated
14 Aug 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41066509

  • 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.

    PubMed 32408905

  • 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.

    PubMed 30785826

  • 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.

    PubMed 28664507

  • 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.

    PubMed 26926676

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Primary Breast Cancer and Her2 Non-overexpressing, run by Women's Cancer Study Group GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01049425, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.

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