Randomized trial for patient with Triple Negative breast tumors who are receiving neo adjuvant chemotherapy

RANDOMIZED PHASE II/III STUDY OF INDIVIDUALIZED NEOADJUVANT CHEMOTHERAPY IN ‘TRIPLE-NEGATIVE’ BREAST TUMORS

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015238-31-NL

Enrollment

270

Registered

2009-10-01

Start date

2009-12-16

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple negative breast cancer treated with neoadjuvant chemotherapy MedDRA version: 20.0 Level: LLT Classification code 10006192 Term: Breast cancer NOS System Organ Class: 100000004864

Interventions

Trade Name: Endoxan Pharmaceutical Form: Powder for infusion INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Proven infiltrating breast cancer with either a primary tumor over 2 cm in size (MRI or ultrasound examination) and/or cytologically proven spread to the axillary lymph nodes. - Patients with 'locally advanced breast cancer' are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. - The tumor must be HER2/neu-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 or 3 at immunohistochemistry). - The tumor must be Estrogen receptor (ER) -negative ( 3.0 x 109/l, platelets > 100 x 109/l). - Adequate hepatic function (ALAT, ASAT and bilirubin 60 ml/min). - Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous radiation therapy or chemotherapy. - Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy. - Pregnancy or breast feeding. - Evidence of distant metastases. Staging examinations must have included a chest roentgenogram, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if bone metastases were excluded by MRI

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At surgery after neo adjuvant chemotherapy; 12-16 weeks after start chemotherapy;Secondary Objective: Secondary endpoint (HRD tumors): Recurrence-free survival and overall survival after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. Secondary endpoint (non-HRD tumors): Recurrence-free survival and overall survival. ;Main Objective: Primary endpoint (HRD tumors): Average Neoadjuvant Response Index (NRI) after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. The NRI incorporates the frequently employed (and widely accepted) endpoint of pathologic Complete Remission (pCR). Primary endpoint (non-HRD tumors): Average Neoadjuvant Response Index (NRI) of the ‘regimen switching’ policy (‘standard treatment’) versus the conditional switching policy. This part of the study will collect preliminary data required to plan for a larger (adequately powered) study. ;Primary end point(s): Primary endpoint (HRD tumors): Average Neoadjuvant Response Index (NRI) after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. The NRI incorporates the frequently employed (and widely accepted) endpoint of pathologic Complete Remission (pCR). Primary endpoint (non-HRD tumors): Average Neoadjuvant Response Index (NRI) of the ‘regimen switching’ policy (‘standard treatment’) versus the conditional switching policy. This part of the study will collect preliminary data required to plan for a larger (adequately powered) study	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At surgery after neo adjuvant chemotherapy; 12-16 weeks after start chemotherapy;Secondary Objective: Secondary endpoint (HRD tumors): Recurrence-free survival and overall survival after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. Secondary endpoint (non-HRD tumors): Recurrence-free survival and overall survival. ;Main Objective: Primary endpoint (HRD tumors): Average Neoadjuvant Response Index (NRI) after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. The NRI incorporates the frequently employed (and widely accepted) endpoint of pathologic Complete Remission (pCR). Primary endpoint (non-HRD tumors): Average Neoadjuvant Response Index (NRI) of the ‘regimen switching’ policy (‘standard treatment’) versus the conditional switching policy. This part of the study will collect preliminary data required to plan for a larger (adequately powered) study. ;Primary end point(s): Primary endpoint (HRD tumors): Average Neoadjuvant Response Index (NRI) after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. The NRI incorporates the frequently employed (and widely accepted) endpoint of pathologic Complete Remission (pCR). Primary endpoint (non-HRD tumors): Average Neoadjuvant Response Index (NRI) of the ‘regimen switching’ policy (‘standard treatment’) versus the conditional switching policy. This part of the study will collect preliminary data required to plan for a larger (adequately powered) study

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoint (HRD tumors): Recurrence-free survival and overall survival after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. Secondary endpoint (non-HRD tumors): Recurrence-free survival and overall survival. ;Timepoint(s) of evaluation of this end point: To be assessed every 3 months after end of treatment, until death	—

Measure

Time frame

Secondary end point(s): Secondary endpoint (HRD tumors): Recurrence-free survival and overall survival after intensified alkylating therapy in comparison to that after ‘standard’ neoadjuvant chemotherapy. Secondary endpoint (non-HRD tumors): Recurrence-free survival and overall survival. ;Timepoint(s) of evaluation of this end point: To be assessed every 3 months after end of treatment, until death

—

Countries

Netherlands

Contacts

Public ContactS. Linn

NKI-AVL

s.linn@nki.nl31205122951

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026