A Phase 2 interventional study of AZD2014 and AZD4547 in Metastatic Breast Cancer, sponsored by UNICANCER. Active, not recruiting at 25 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by UNICANCER · Phase 2, Interventional, and Treatment
Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).
Screening phase:
New frozen biopsy or an archived frozen sample or ctDNA sample will be sent to the genomic platforms for DNA extraction and genomic analysis (DNA microarrays and Next generation sequencing).
Patients can be considered as pre-eligible for the targeted substudy 1 randomisation phase when both following mandatory conditions have been met: stable or responding disease has been observed (investigator judgment) after 6 to 8 cycles of chemotherapy (or at least after 4 cycles of chemotherapy if stopped for toxicity) and targetable alteration has been identified by the Molecular Tumor Board (MTB).
If not eligible for the substudy 1 randomisation phase, patients can be considered as pre-eligible for the immune substudy 2 randomization phase when both following mandatory conditions are met: stable or responding disease (investigator judgment) is observed after 6 to 8 cycles of chemotherapy (or at least after 4 cycles if treatment was stopped due to toxicity) AND not eligible to randomization in the substudy 1 (because patient had no targetable alteration identified by the Molecular Tumor Board, or failed to have a genomic profile for the tumor [low tumor cells percentage, technical issue during genomic analysis, etc.], or a non inclusion criteria that precluded entry into the substudy 1)
Randomization phase:
The mandatory post-chemotherapy wash-out period, of 28 days for 21 or 28 day-cycle chemotherapies or of 15 days for weekly (except monoclonal antibodies) or daily chemotherapies,will provide time to achieve all the required tests and examinations.
The randomization program will allocate the following treatments with a 2:1 ratio in favor of Arm A of the considered substudy:
Substudy 1 : targeted therapies versus standard maintenance chemotherapy
Substudy 2 : immunotherapy versus standard maintenance chemotherapy
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1,460 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Screening phase:
Inclusion Criteria:
Exclusion criteria:
Randomized phase:
Substudy 1:
Inclusion Criteria:
Exclusion Criteria:
Substudy 2:
Inclusion Criteria:
Exclusion Criteria:
Arm A1 / Targeted Arm : targeted maintenance from a list of 8 targeted drugs guided by the genomic analysis, AZD2014 tablet per os 50 mg bd, continuous dosing, AZD4547 tablet per os 80 mg bd, 2 weeks on/1 week off, AZD5363 capsule per os 480 mg bd, 4 days on/3 days off, AZD8931 tablet per os 40 mg bd, continuous dosing, selumetinib capsule per os 75 mg bd, continuous dosing, vandetanib tablet per os 300 mg od, continuous dosing, bicalutamide tablet per os 150 od, continuous dosing, olaparib tablet per os 300 mg bd, continuous dosing
Drug: AZD2014 · Drug: AZD4547 · Drug: AZD5363 · Drug: AZD8931 · Drug: Selumetinib · Drug: Vandetanib · Drug: Bicalutamide · Drug: Olaparib
Arm B1/ maintenance Standard Chemotherapy Arm : such as Anthracyclines (Doxorubicin or Epirubicin or Liposomal Doxorubicine), Taxanes (Paclitaxel, Docetaxel), Cyclophosphamide, DNA Intercalators (Capecitabine, 5-FU, gemcitabine), Methotrexate, Vinca alkaloids (Vinorelbine, Vinblastine, Vincristine), Platinum based chemotherapies (Carboplatin, Cisplatin), Bevacizumab, Mitomycin C, Eribulin
Drug: Anthracyclines · Drug: Taxanes · Drug: cyclophosphamide · Drug: DNA intercalators · Drug: Methotrexate · Drug: vinca alkaloids · Drug: Platinum based chemotherapies · Drug: Bevacizumab · Drug: Mitomycin C · Drug: Eribulin
Arm A2/ Immunotherapy arm: maintenance with MEDI4736 for patient without actionable genomic alterations or non eligible to Targeted substudy 1, MEDI4736 Intra-venous 10 mg/kg, Q2W
Drug: MEDI4736
Arm B2/ maintenance Standard Chemotherapy Arm : such as Anthracyclines (Doxorubicin or Epirubicin or Liposomal Doxorubicine), Taxanes (Paclitaxel, Docetaxel), Cyclophosphamide, DNA Intercalators (Capecitabine, 5-FU, gemcitabine), Methotrexate, Vinca alkaloids (Vinorelbine, Vinblastine, Vincristine), Platinum based chemotherapies (Carboplatin, Cisplatin), Bevacizumab, Mitomycin C, Eribulin
Drug: Anthracyclines · Drug: Taxanes · Drug: cyclophosphamide · Drug: DNA intercalators · Drug: Methotrexate · Drug: vinca alkaloids · Drug: Platinum based chemotherapies · Drug: Bevacizumab · Drug: Mitomycin C · Drug: Eribulin
Target: m-TOR
Target: EGFR
Target: AKT
Target: HER2, EGFR
Target: MEK
Also known as: ARRY-142866
Target: VEGF, EGFR
Also known as: CAPRELSA
target: Androgen receptor
Also known as: Casodex
Target: PARP
Also known as: Lynparza
DNA intercalation
Also known as: Doxorubicin, Epirubicin, liposomal doxorubicin
Target: mitotic tubulin and microtubules
Also known as: paclitaxel, docetaxel
Alkylating agents
Also known as: Novatrex, Imeth
DNA intercalators
Also known as: capecitabine, 5-FU, gemcitabine
DNA intercalators
Target: mitotic tubulin and microtubules
Also known as: vinorelbine, vinblastine, vincristine
Platinum based chemotherapies
Also known as: Platinum, carboplatin, cisplatin
Target: VEGF
Also known as: Avastin
Alkylating agents
Also known as: Ametycine
Microtubule modulator
Also known as: Halaven
Target: PD-L1
Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm
To evaluate whether treatment with targeted agents guided by high throughput molecular analysis (CGH array, next generation sequencing) improves progression-free survival as compared to standard maintenance therapy in patients with metastatic Breast Cancer
Time frame: from randomization to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
progression-free survival in patients treated with anti-PDL1 antibody (MEDI4736) compared to standard maintenance therapy arm
To evaluate whether treatment with MEDI4736 improves progression-free survival as compared to standard maintenance therapy in patients with metastatic Breast Cancer
Time frame: from randomization to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
overall survival in each substudy
To evaluate whether treatment with targeted agents guided by high throughput molecular analysis (CGH array, next generation sequencing) or MEDI4736 improves overall survival as compared to standard maintenance therapy in patients with metastatic Breast Cancer
Time frame: from randomization to death (any cause), up to 16 months
overall response rates and changes in tumor size in each substudy
tumor response is defined as a complete or partial response, upon RECIST v1.1 criteria
Time frame: tumor response is assessed every 21 days from treatment initiation until first progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
evaluate safety, in each substudy
Toxicities are graded according to the CTCAE V4
Time frame: toxicities will be assessed during the whole treatment period (4 months expected in average) followed by a 1-year post-treatment follow-up period, and reported during the visits scheduled by the study flow chart
efficacy (response rate, change in tumor size, progression-free survival, overall survival) and safety of each individual targeted agent (substudy 1)
tumor response is defined as a complete or partial response, upon RECIST v1.1 criteria
Time frame: tumor response is assessed every 21 days from treatment initiation until first progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
correlate molecular characteristics in patients with the efficacy endpoints (response rate, progression-free and overall survival) in each substudy
tumor response is defined as a complete or partial response, upon RECIST v1.1 criteria
Time frame: from randomization or treatment initiation to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
Plan to share: Undecided
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