Etude : ATTAIN / NEKTAR 15 102 14

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : ATTAIN / NEKTAR 15 102 14

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Thérapie ciblée

Cadre réglementaire : RIPH2

Dernière MÀJ : 06/05/2021
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Informations complémentaires
Schéma : In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
Intervention: Drug: NKTR-102
Active Comparator: Treatment of Physician's Choice (TPC)
- In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Drug: Eribulin
Drug: Ixabepilone
Drug: Vinorelbine
Drug: Gemcitabine
Drug: Paclitaxel
Drug: Docetaxel
Drug: Nab-paclitaxel

Phase : III

Stade : Métastatique

1, 2, 3, 4
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Female or male, age ≥ 18 years.
- Histologically-confirmed carcinoma of the breast (either the primary or metastatic lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable or non-measurable disease according to RECIST version 1.1.
- Patients must have a history of brain metastases that are non-progressing.
- For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen must have been administered for the indication of metastatic disease.Depending on receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in this trial; hormonal and/or human epidermal growth factor receptor 2 (HER2) -targeted agents may be required.
- Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).
- Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.
- All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory.
- Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.
- Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug.

Critères de non-inclusion : - Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization.
- High-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic).
- Major surgery within 28 days prior to randomization.
- Concomitant use of any anticancer therapy or use of any investigational agent(s).
- Received prior treatment for cancer with a camptothecin-derived agent.
- Lesions on imaging, by cerebrospinal fluid or with neurological findings that are consistent with leptomeningeal disease or meningeal carcinomatosis.
- Chronic or acute GI disorders resulting in diarrhea of any severity grade.
- Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization.
- Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.
- Hepatitis B or C, tuberculosis, or HIV.
- Cirrhosis.
- Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization.
- Daily use of oxygen supplementation.
- Significant known cardiovascular impairment.
- Prior treatment with NKTR-102.
- Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance.
- Known intolerance or hypersensitivity to any of the products used in this study or their excipients.
- For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Jean-Christophe THERY


Statut de l'essai : CLOS

MAJ : 24/01/2020