Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer (NCT01658462) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer
France51 participantsStarted 2013-05
Plain-language summary
National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old
* Histologically or cytologically confirmed adenocarcinoma of the breast
* Locally recurrent or metastatic disease
* HER 2 negative status
* Requiring a first or a second-line chemotherapy for locally recurrent or metastatic disease.
* Prior first line chemotherapy not containing Docetaxel
* Measurable or evaluable disease according to RECIST 1.1 criteria
* Allowed prior chemotherapy as follows :
* Docetaxel in the neoadjuvant or adjuvant setting is allowed provided that relapse has been observed more than 12 months after the end of docetaxel treatment
* Bevacizumab in 1st line is allowed with a wash-out of 4 weeks, with recovery to NCI-CTCAE v3.0 toxicity
* ECOG performance status 0-1
* Adequate bone marrow, hepatic and renal functions as evidence by the following:
* Hemoglobin ≥ 10 G/100 mL
* Neutrophils count ≥ 1500 /mm3
* Platelets ≥ 100 000 /mm3
* Total bilirubin ≤ ULN (ULN:Upper Limit of Normal)
* SGOT/SGPT ≤ 1.5 x ULN (≤ 2.5 x ULN in case of hepatic metastasis)
* Serum alkaline phosphatase ≤ 2.5 x ULN
* Creatinin clearance ≥ 45 ml/min or creatinin ≤ 1.5 x ULN
* Proteinuria \< CTCAE grade 2
* Coagulation parameters: International normalised ratio (INR) ≤ 2, prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 50% of deviation of institutional ULN
* Effective contraception for patients (male and female) with reproductive potential during their entire participation in the study and during 3 months af…
What they're measuring
1
Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)
Timeframe: baseline, every 9 weeks (or 3 cycles), up to 6 months