Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2 (TRAIN-2)
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| ClinicalTrials.gov Identifier: NCT01996267 |
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Recruitment Status :
Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : March 29, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer HER2 Positive | Drug: PTC+Pertuzumab Drug: FEC-T+Pertuzumab | Phase 3 |
Upfront trastuzumab treatment is beneficial to patients with HER2 positive breast cancer. The potential synergistic cardiotoxicity of trastuzumab and anthracyclines has led to the development of non-anthracycline containing regimens, which have shown high pathologic complete response rates. Anthracyclines remain very active in HER2 positive breast cancer, however, and increasing evidence now supports safe combination of trastuzumab and epirubicin. Therefore, the addition of epirubicin to a non-anthracycline containing regimen may further improve outcome for patients with HER2 positive breast cancer.
Several reports confirmed benefit of dual HER2 blockade by adding pertuzumab to a trastuzumab containing neoadjuvant regimen. The results of the combined treatment in the Neosphere study, however, are similar to what we found in a phase II trial using a weekly paclitaxel, trastuzumab, carboplatin combination with pCR rates of approximately 44%. Adding pertuzumab to this regimen is likely to also increase the high pCR rate and to add substantial benefit to patients.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 437 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Optimizing Neoadjuvant Systemic Treatment for HER2 Positive Breast Cancer - the TRAIN-2 Study |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2030 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: FEC-T +Pertuzumab
Fluorouracil; 500 mg/m2; day 1 Epirubicine; 90 mg/m2; day 1 Cyclophosphamide; 500 mg/m2; day 1 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg) Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle is repeated every 21 days
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Drug: FEC-T+Pertuzumab
Cycle is repeated every 21 days
Other Names:
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Active Comparator: PTC+Pertuzumab
Paclitaxel; 80 mg/m2; day 1,8 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg); day 1 Carboplatin; AUC=6; day 1 Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle repeated every 21 days
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Drug: PTC+Pertuzumab
Cycle repeated every 21 days
Other Names:
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- Number of patients with pathological complete response [ Time Frame: at week 30 ]To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancer
- Number of patients with grade >2 adverse events as a measure of safety and tolerability [ Time Frame: up to week 35 ]to describe the safety of the various regimens toxicity is compared between the two arms
- identify prognostic and predictive biomarkers for pCR [ Time Frame: within one year after end of treatment ]To identify prognostic and predictive biomarkers for pCR after neoadjuvant treatment
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed infiltrating breast cancer
- Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
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Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
•>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
•HER2 gene amplification defined as >6 HER2 gene copies per nucleus by in situ hybridization.
- Age ≥18
- Eastern Cooperative Oncology Group performance status ≤1
- Adequate bone marrow function (ANC >1.5 x 109/l, platelets >100 x 109/l)
- Adequate hepatic function (ALAT, ASAT and bilirubin <2.5 times upper limit of normal)
- Adequate renal function (creatinine clearance >50 ml/min)
- LVEF ≥50% measured by echocardiography or MUGA
- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Absence of any medical condition that would place the patient at unusual risk.
- Signed written informed consent
Exclusion Criteria:
- previous radiation therapy or chemotherapy
- other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.
- evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.
- concurrent anti-cancer treatment or another investigational drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996267
Show 33 study locations
| Principal Investigator: | Gabe S Sonke, MD | Antoni van Leeuwenhoek, Amsterdam |
| Responsible Party: | The Netherlands Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01996267 |
| Other Study ID Numbers: |
M13TRT |
| First Posted: | November 27, 2013 Key Record Dates |
| Last Update Posted: | March 29, 2024 |
| Last Verified: | March 2024 |
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neoadjuvant breast cancer HER2 positive |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Cyclophosphamide Carboplatin Fluorouracil Trastuzumab Pertuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents, Immunological |