Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005637-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.
In a clinical context, there is a lack of molecular compounds with demonstrated clinical activity in delaying/reversing resistance to endocrine agents. CDK 4/6 inhibitors may represent a biologically-driven option in this context.
With the present study investigators aim to complement the ongoing trial on PD0332991 by acquiring information on its clinical activity in post-menopausal patients with ER positive, Her2 negative advanced breast cancer patients already pretreated with a first-line or second line endocrine therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Palbociclib monoterapy |
|
| Arm B | Experimental | Palbociclib + HT (Anastrozole, Letrozole, Exemestane, Fulvestrant) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | Palbociclib 125 mg/day orally in an ongoing 3:1 schedule (3 weeks on/1 week off) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complete response (CR), partial response (PR) or stable disease (SD) ≥24 weeks (clinical benefit) | All randomized patients with adequate baseline disease assessment with measurable disease, the disease under study and who start treatment on the assigned arm will be considered evaluable for clinical benefit (CB). The probability of CB on each randomized treatment arm will be estimated by dividing the number of patients with CB by the number of evaluable patients randomized to the treatment arm. | Baseline up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is the time from randomization date to date of first documentation of progression or death due to any cause, whichever occurs first. Documentation of progression must be by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. All patients randomized will be considered evaluable for PFS. | Baseline up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | All patients treated with at least one dose of trial treatment will be included in safety analyses. Adverse events will be summarized by treatment and by the frequency of patients experiencing treatment emergent adverse events corresponding to body systems and MedDRA preferred term. Adverse events will be graded by worst NCI CTCAE v4.0 grade. | Baseline up to 3 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| LUCA MALORNI, MD | Azienda USL 4 Prato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Papa Giovanni Xxiii | Bergamo | 24127 | Italy | |||
| Ospedale Antonio Perrino |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33761970 | Derived | Galardi F, De Luca F, Biagioni C, Migliaccio I, Curigliano G, Minisini AM, Bonechi M, Moretti E, Risi E, McCartney A, Benelli M, Romagnoli D, Cappadona S, Gabellini S, Guarducci C, Conti V, Biganzoli L, Di Leo A, Malorni L. Circulating tumor cells and palbociclib treatment in patients with ER-positive, HER2-negative advanced breast cancer: results from a translational sub-study of the TREnd trial. Breast Cancer Res. 2021 Mar 24;23(1):38. doi: 10.1186/s13058-021-01415-w. | |
| 29893790 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Anastrozole | Drug | Continuation of prior anastrozole 1mg/day orally in a continuous regimen |
|
| Letrozole | Drug | Continuation of prior letrozole 2.5mg/day orally in a continuous regimen |
|
| Exemestane | Drug | Continuation of prior exemestane 25mg/day orally in a continuous regimen |
|
| Fulvestrant | Drug | Continuation of prior fulvestrant 500mg intramuscular injection every 4 weeks in a continuous regimen |
|
| Objective Response (OR) | All randomized patients with adequate baseline disease assessment with measurable disease, the disease under study and who start treatment on the assigned arm will be considered evaluable for objective response (CR or PR). The probability of OR on each randomized treatment arm will be estimated by dividing the number of patients with OR by the number of evaluable patients randomized to the respective treatment arm ("response rate"). | Baseline up to 3 years |
| Overall Survival (OS) | OS is the time from randomization date to date of death due to any cause. All patients randomized will be considered evaluable for OS. | Baseline up to 6 years |
| Time to Progression (TTP) | TTP is the time from randomization date to date of first documentation of objective progression. All patients randomized will be considered evaluable for TTP. | Baseline up to 3 years |
| Duration of Response (DR) | For patients with an objective response (CR or PR), duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death. Date of first documentation of progression and date of first documentation of CR or PR will be based on investigator assessment of response. | Baseline up to 3 years |
| Brindisi |
| 72100 |
| Italy |
| Istituto Europeo Oncologia | Milan | 20141 | Italy |
| A.O.U. Federico Ii Di Napoli | Naples | 80131 | Italy |
| Fondazione Maugeri | Pavia | 27100 | Italy |
| A.O.U. S. Maria Della Misericordia Di Udine | Udine | 33100 | Italy |
| Derived |
| Malorni L, Curigliano G, Minisini AM, Cinieri S, Tondini CA, D'Hollander K, Arpino G, Bernardo A, Martignetti A, Criscitiello C, Puglisi F, Pestrin M, Sanna G, Moretti E, Risi E, Biagioni C, McCartney A, Boni L, Buyse M, Migliaccio I, Biganzoli L, Di Leo A. Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial. Ann Oncol. 2018 Aug 1;29(8):1748-1754. doi: 10.1093/annonc/mdy214. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| C056516 | exemestane |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided