Women With Primary Breast CancerPhase 2NCT02225652

A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer.

A Phase 2 study testing FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel in people with Women With Primary Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

TITLE: A Phase II Study of Dose Density Regimen with Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days with Filgrastim Support followed by Weekly Paclitaxel in Women with Primary Breast Cancer. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Women With Primary Breast Cancer
What is being tested?: FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteItaly
Study dates: Sep 2010to Jul 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have histologically or cytologically confirmed primary breast cancer
Age ≥18 and < 70 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (see appendix B)
>4 positive axillary nodes or high-risk breast cancer with <4 node-positive or node negative disease. Patients <4 node-positive or node negative disease are eligible if the tumor is >1cm and two or more of the following are present: histologic grade 3, Ki67>30%, estrogen receptor (ER) negativity, or lymphovascular invasion [39]
Adequate hematological, hepatic and renal function, as follows: hemoglobin ≥ 9 g/dl, absolute neutrophil count ≥1,500/mL, platelets ≥100,000/mL, total bilirubin ≤1.5 x ULN, alkaline phosphatase, AST(SGOT) and ALT(SGPT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases present), serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance >50 mL/min. Either INR or APTT < 1.5 x ULN;
Known hormone receptor status (ER/PgR or ER alone);

Show all 13Show fewer

Must have received no other chemotherapy regimen.
Baseline LVEF ≥55% measured by echocardiography
No over expression and/or amplification of HER2 in the invasive component of the primary tumour (in case of neoadjuvant treatment, tissue sample used for HER2 testing should be collected before neoadjuvant treatment starts)
Negative pregnancy test no more than 7 days before randomization; test pregnancy can be omitted only in women without any reproductive potential (e.g.: postmenopausal women, i.e. amenorrhoea ≥2 years or with previous hysterectomy or bilateral ovariectomy). Women of child-bearing potential must agree to use adequate contraception at the time of randomization and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician and coordinating centre (CC) immediately; women in lactation period must be excluded;
Completion of all necessary baseline laboratory and radiological investigations
Ability to understand and the willingness to sign a written informed consent document.
Signed written informed consent

Who cannot join

Metastatic disease
Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
Contraindications or hypersensitivity to study drugs;
Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix.
NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of invasive breast cancer or melanoma, at any time, are excluded from this study.
Serious cardiac illness or medical conditions including but not confined to:

Show all 24Show fewer

History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <55%);
High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled);
Angina pectoris requiring antianginal medication;
Clinically significant valvular heart disease;
Evidence of transmural infarction on ECG;
Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg);
Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness;
Any of the following abnormal laboratory tests immediately prior to randomisation:
serum total bilirubin >1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 x ULN) is allowed
alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) >2.5 x ULN;
alkaline phosphatase (ALP) >2.5 x ULN;
serum creatinine >2.0 x ULN;
total white blood cell count (WBC) <2.5 x 109/L;
absolute neutrophil count <1.5 x 109/L;
platelets <100 x 109/L.
Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication. Subjects with ulcerative colitis are also excluded;
Pregnant, lactating or women of childbearing potential without a negative pregnancy test - urine or serum, within 7 days prior to randomization, irrespective of the method of contraception used, including tubal ligation.
Women of childbearing potential, including women whose last menstrual period was <12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment. (adequate contraceptive measures are intra-uterine device, barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable or implant hormonal contraceptives are not allowed on this study)

Trial locations and contacts

1 site in 1 country.

Italy1 site

Irccs Irst
Meldola, FC, 47014

Other trials in Italy

About this study

PROTOCOL CODE: IRST 174.05

PHASE: II

STUDY DESIGN: Pharmacological, open-label, prospective, not randomized, monocentric trial

DESCRIPTION OF STUDY TREATMENT:

FEC + filgrastim x 3 cycles q 14-21 days

Day 1 and day 4 = FEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60 mg/m2 IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes).

From day 7 until hematological recovery = Filgrastim 300 microg s.c.

After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly for 8 cycles, at day 1).

NUMBER OF SUBJECTS: in the first stage, 11 patients have been planned, with an additional 27 patients to the second stage if at least 7 patients complete the planned treatment.

OBJECTIVES

Primary objective: this trial is designed to assess feasibility of the proposed regimen with regard to toxicity and deliverability. Tolerability is defined as absence of any grade 3 or higher nonhematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the administration of filgrastim). Deliverability is measured as the percentage of patients who complete the planned treatment.

Secondary objectives:

Relapse-free survival: measured from enrollment to the first date between date of documented relapse (or death) or date of last tumor assessment (if no documented relapse), or the date of last tumor assessment before the start of any further antitumor therapy not planned in the protocol.
Overall survival: measured from enrollment to the date of death of any cause or last follow-up.

CORRELATIVE/SPECIAL STUDIES: to evaluate retrospectively potential biomarkers of activity and toxicity of this regimen, blood and plasma samples until 15 mL each one will be collected at study entry, before first docetaxel administration and 3-4 weeks after last docetaxel administration. Moreover, a paraffin block or specimens of the primary tumor will be collected for biological studies.

STATISTICAL CONSIDERATIONS: This trial is designed to assess feasibility of the proposed regimen with regard to toxicity and deliverability.

Tolerability is defined as absence of any grade 3 or higher non-hematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the administration of filgrastim).

A Simon two-stage design has been used with a 60% tolerability rate considered not promising and an 80% tolerability rate as promising, and probability of type I and type II errors has been set to be 0.10.

In the first stage, 11 patients have been planned, with an additional 27 patients to the second stage if at least 7 patients complete the planned treatment. The regimen would be considered tolerable and worthy of further study if at the end of the trial 27 out 38 patients complete the planned treatment.

Conditions: Women With Primary Breast Cancer
Being tested: FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxelDrug

Study groups in NCT02225652
Study group	Role	What they receive
FEC + filgrastim x 3 cycles q 14-21 days and Weekly Paclitaxel	Experimental	FEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60 mg/m2 IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes). From day 7 until hematological recovery = Filgrastim 300 microg s.c. After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly for 8 cycles, at day 1). Receives: Drug: FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability of the treatment
Tolerability is defined as absence of any grade 3 or higher non-hematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the administration of filgrastim).
Measured: 18 months
Toxicity
All patients will be evaluated for toxicity according to NCI CTCAE v3.0 criteria. All patients will be evaluable for toxicity from the time of their first treatment. Safety analysis will be based on the population of all treated (at least one cycle) patients.
Measured: 18 months

Secondary outcomes (4)

Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression.
Measured: 18 months
Overall survival (OS)
Overall survival (OS) is defined as the duration of time from start of treatment to last follow-up visit or death.
Measured: 18 months
Relapse-free survival
The relapse-free survival is measured from enrollment to the first date between date of documented relapse/progression (or death) or date of last tumor assessment (if no documented progression) or the date of last tumor assessment before the start of any further antitumor therapy not planned in the protocol.
Measured: 18 months
Kaplan-Meier curves
Time related outcomes (PFS, OS) will be described using Kaplan-Meier curves. 95% Confidence Intervals for median time and for each year of follow-up will be calculated with non-parametric methods.
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Jul 2014

First posted26 Aug 2014 (estimated)
Study startSep 2010
Primary completionSep 2013
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Women With Primary Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02225652
Sponsor's protocol ID: IRST174.05
Other IDs: 2010-020772-38
Status last verified: Aug 2014
First submitted: 25 Aug 2014
Last updated: 26 Aug 2014
Results posted: No
Data monitoring committee: No

Publications

Pietri E, Andreis D, Fabbri F, Menna C, Schirone A, Kopf B, Rocca A, Amadori D, De Giorgi U. A phase II study of a dose-density regimen with fluorouracil, epirubicin, and cyclophosphamide on days 1 and 4 every 14 days with filgrastim support followed by weekly paclitaxel in women with primary breast cancer. Oncologist. 2015 Mar;20(3):239-40. doi: 10.1634/theoncologist.2014-0326. Epub 2015 Jan 30.
PubMed 25637379

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Women With Primary Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer.
ClinicalTrials.gov ID: NCT02225652
Acronym / sponsor ID: IRST174.05
Conditions: Women With Primary Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
Study start: Sep 2010
Primary completion: Sep 2013 (actual)
Study completion: Jul 2014 (actual)
First posted: 26 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PROTOCOL CODE: IRST 174.05

PHASE: II

STUDY DESIGN: Pharmacological, open-label, prospective, not randomized, monocentric trial

DESCRIPTION OF STUDY TREATMENT:

FEC + filgrastim x 3 cycles q 14-21 days

Day 1 and day 4 = FEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60 mg/m2 IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes).

From day 7 until hematological recovery = Filgrastim 300 microg s.c.

After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly for 8 cycles, at day 1).

NUMBER OF SUBJECTS: in the first stage, 11 patients have been planned, with an additional 27 patients to the second stage if at least 7 patients complete the planned treatment.

OBJECTIVES

Secondary objectives:

Relapse-free survival: measured from enrollment to the first date between date of documented relapse (or death) or date of last tumor assessment (if no documented relapse), or the date of last tumor assessment before the start of any further antitumor therapy not planned in the protocol.
Overall survival: measured from enrollment to the date of death of any cause or last follow-up.

STATISTICAL CONSIDERATIONS: This trial is designed to assess feasibility of the proposed regimen with regard to toxicity and deliverability.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FEC + filgrastim x 3 cycles q 14-21 days and Weekly Paclitaxel	Experimental	Drug: FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxelFEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60 mg/m2 IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes). From day 7 until hematological recovery = Filgrastim 300 microg s.c. After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly for 8 cycles, at day 1).

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Patients must have histologically or cytologically confirmed primary breast cancer
Age ≥18 and < 70 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (see appendix B)
>4 positive axillary nodes or high-risk breast cancer with <4 node-positive or node negative disease. Patients <4 node-positive or node negative disease are eligible if the tumor is >1cm and two or more of the following are present: histologic grade 3, Ki67>30%, estrogen receptor (ER) negativity, or lymphovascular invasion [39]
Adequate hematological, hepatic and renal function, as follows: hemoglobin ≥ 9 g/dl, absolute neutrophil count ≥1,500/mL, platelets ≥100,000/mL, total bilirubin ≤1.5 x ULN, alkaline phosphatase, AST(SGOT) and ALT(SGPT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases present), serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance >50 mL/min. Either INR or APTT < 1.5 x ULN;

Key exclusion criteria (24 listed)

Metastatic disease
Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
Contraindications or hypersensitivity to study drugs;
Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix.
NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of invasive breast cancer or melanoma, at any time, are excluded from this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel	Drug	FEC + filgrastim x 3 cycles q 14-21 days and Weekly Paclitaxel

Primary outcome

Tolerability of the treatment
Time frame: 18 months
Tolerability is defined as absence of any grade 3 or higher non-hematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the administration of filgrastim).
Toxicity
Time frame: 18 months
All patients will be evaluated for toxicity according to NCI CTCAE v3.0 criteria. All patients will be evaluable for toxicity from the time of their first treatment. Safety analysis will be based on the population of all treated (at least one cycle) patients.

4 secondary outcomes

Progression-free survival (PFS)
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
Relapse-free survival
Time frame: 18 months
Kaplan-Meier curves
Time frame: 18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
Derived from this study: PubMed 25637379Pietri E, Andreis D, Fabbri F, Menna C, Schirone A, Kopf B, Rocca A, Amadori D, De Giorgi U. A phase II study of a dose-density regimen with fluorouracil, epirubicin, and cyclophosphamide on days 1 and 4 every 14 days with filgrastim support followed by weekly paclitaxel in women with primary breast cancer. Oncologist. 2015 Mar;20(3):239-40. doi: 10.1634/theoncologist.2014-0326. Epub 2015 Jan 30.

Related trials for Women With Primary Breast Cancer

Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability of the treatment (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02225652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.