Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)

NCT01216111 | Completed Phase 3

• 1 other identifier: Fudan TNBC Adjuvant CT
• Study Type: interventional
• Target: 647
• Locations: 0 countries
• Sites: N/A

Brief Summary

Previous studies in Western country show that triple-negative breast cancer has aggressive clinical and pathological features compared with non-triple negative breast cancer, including onset at a young age, advanced clinical stage, high histologic and nuclear grade and more distant recurrence. According to the characteristics of triple negative breast tumor, the TNBC patients can benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The only systemic therapy currently available is chemotherapy, and prognosis remains poor. It becomes more and more important to investigate the sensitive chemotherapy regimen for triple negative patients. Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. Triple negative breast cancer patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies. The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to triple negative breast cancer compared with CEF followed by docetaxel.

Conditions

Triple Negative Breast Cancer

Keywords

triple negative breast cancer，local recurrence,distant metastasis

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  time from random assignment to first relapse (local, regional and distant), contralateral breast cancer

  5 year

Secondary Outcomes (4)

• distant disease-free survival

  5 year

• relapse-free survival

  5 year

• disease-free survival gBRCA1 mutation carriers and homologous recombination repair (HRR)-related gene mutation carriers

  5 year

• overall survival

  5 year

Study Arms (2)

6 cycles of PC adjuvant chemotherapy

EXPERIMENTAL

paclitaxel 80 mg/m2 and carboplatin (area under the curve \[AUC\]= 2) on day 1, 8, 15 every 28 days for six cycles

Drug: Paclitaxel Cisplatin

3 cycles of FEC followed by 3 cycles of Docetaxel

ACTIVE COMPARATOR

fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously

Drug: fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)

Interventions

Paclitaxel Cisplatin DRUG

Paclitaxel 80 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15 1 cycle = 28days PC\*6

6 cycles of PC adjuvant chemotherapy

fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T) DRUG

fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously

3 cycles of FEC followed by 3 cycles of Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged from 18 to 70 years;
• Histologically proven invasive unilateral breast cancer (regardless of the type);
• Initial clinical condition compatible with complete initial resection;
• No residual macro or microscopic tumor after surgical excision;
• Beginning of chemotherapeutic treatment no later than day 42 after the initial surgery;
• positive lymph node or negative lymph node with tumor size \> 1.0cm
• Patient presenting one of the following criteria (reviewed before randomization by referent pathologist):
• Triple negative （ER-PR-Her-2-） Hormone receptor negativity is defined as ER\<1%, PR\<1% (IHC), HER2 negativity is defined as IHC 0-1+, or \[IHC 2+ and FISH or CISH negative\].
• No clinically or radiologically detectable metastases (M0);
• No peripheral neuropathy \> 1;
• WHO Performance status (ECOG) of 0 or 1;
• Adequate recovery from recent surgery (at least one week must have elapsed from the time of a minor surgery (excluding breast biopsy); at least three weeks for major surgery);
• Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin \> 9 g/dl);
• Adequate hepatic function: ASAT and ALAT ≤ 3 ULN alkaline phosphatases ≤ 2.5 ULN,total bilirubin ≤ 1,5 ULN;
• Adequate renal function: serum creatinine ≤ 1 ULN;

You may not qualify if:

• Bilateral breast cancer or patient with controlateral DCIS;
• Any metastatic impairment, including homolateral sub-clavicular node involvement,regardless of its type;
• Any T4 lesion (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
• ER+ or PR+ or Her-2 overexpression
• Any clinically or radiologically suspect and non-explored damage to the controlateral breast;
• Any chemotherapy, hormonal therapy or radiotherapy before surgery;
• Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheral ephitelioma) in the preceding 5 years, including invasive controlateral breast cancer;
• Patients already included in another therapeutic trial involving an experimental drug;
• Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
• LEVF \< 50% (MUGA scan or echocardiography);
• Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (\>150/90), myocardial infarction or cerebral vascular accidents) within 6 months prior to randomization;
• Known prior severe hypersensitivity reactions to agents containing Cremophor EL;
• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 8 weeks after treatment completion;
• Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase;
• Women with a positive pregnancy test en enrollment or prior to study drug administration;

Sponsors & Collaborators

• Fudan University: lead
• Chinese Anti-Cancer Association: collaborator

Related Publications (8)

• Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.

  PMID: 10963602 BACKGROUND

• Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.

  PMID: 17438091 BACKGROUND

• Yehiely F, Moyano JV, Evans JR, Nielsen TO, Cryns VL. Deconstructing the molecular portrait of basal-like breast cancer. Trends Mol Med. 2006 Nov;12(11):537-44. doi: 10.1016/j.molmed.2006.09.004. Epub 2006 Sep 29.

  PMID: 17011236 BACKGROUND

• Reis-Filho JS, Tutt AN. Triple negative tumours: a critical review. Histopathology. 2008 Jan;52(1):108-18. doi: 10.1111/j.1365-2559.2007.02889.x.

  PMID: 18171422 BACKGROUND

• Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. doi: 10.1016/S1470-2045(07)70074-8.

  PMID: 17329194 BACKGROUND

• Dent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, Lickley LA, Rawlinson E, Sun P, Narod SA. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34. doi: 10.1158/1078-0432.CCR-06-3045.

  PMID: 17671126 BACKGROUND

• Hayes DF, Ethier S, Lippman ME. New guidelines for reporting of tumor marker studies in breast cancer research and treatment: REMARK. Breast Cancer Res Treat. 2006 Nov;100(2):237-8. doi: 10.1007/s10549-006-9253-5. Epub 2006 Jun 14. No abstract available.

  PMID: 16773436 BACKGROUND

• Yu KD, Ye FG, He M, Fan L, Ma D, Mo M, Wu J, Liu GY, Di GH, Zeng XH, He PQ, Wu KJ, Hou YF, Wang J, Wang C, Zhuang ZG, Song CG, Lin XY, Toss A, Ricci F, Shen ZZ, Shao ZM. Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1390-1396. doi: 10.1001/jamaoncol.2020.2965.

  PMID: 32789480 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

TP protocol; Docetaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: January 1, 2011
• Primary Completion: April 20, 2016
• Study Completion: April 20, 2016
• Last Updated: May 19, 2020

Record last verified: 2020-05