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Breast CancerPhase 2TRIUMPHNCT02053597

TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen

A Phase 2 study testing Doxorubicin and paclitaxel in people with Breast Cancer, run by Jules Bordet Institute at 4 sites in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Recently, there has been a rising trend of delaying childbearing and hence more women are diagnosed with breast cancer before completing their families. Given the continuous decline in recurrences and death secondary to breast cancer and the reassuring data on the safety of pregnancy following breast cancer more women… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Doxorubicin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesBelgium
Study dates
Oct 2014to Jul 2015
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 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ≤ 40 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
  • Negative estrogen (ER) and progesterone receptor (PgR) status.
  • Baseline left ventricular ejection fraction (LVEF) ≥50% measured by an echocardiogram or MUGA.
  • Interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
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  • Known HER2/neu status.
  • Negative pregnancy test within 14 days prior to starting chemotherapy.
  • Adequate hematologic, hepatic and renal function.
  • Signed informed consent.

Who cannot join

  • History of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
  • Previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).
  • Ovarian insufficiency defined as serum FSH > 20 IU/L at the local laboratory, anytime during the menstrual cycle.
  • Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
  • Pregnant or breastfeeding patients.
  • Inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. Effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm - also in conjugation with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
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  • Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.
  • Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
  • Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
  • Known sensitivity to any of the study medications.

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • GZA Ziekenhuisen Campus Sint-Augustinus - Iridium Kankernetwerk

    Antwerp, Wilrijk, 2610

  • Jules Bordet Institute

    Brussels, Brussels Capital, 1000

  • Hôpital Erasme

    Brussels, Brussels Capital, 1070

  • Clinique et Maternité Sainte Elisabeth

    Namur, Namur, 5000

Other trials in Belgium

About this study

Official title: A Phase II TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen Composed of Doxorubicin and Paclitaxel

Recently, there has been a rising trend of delaying childbearing and hence more women are diagnosed with breast cancer before completing their families. Given the continuous decline in recurrences and death secondary to breast cancer and the reassuring data on the safety of pregnancy following breast cancer more women are inquiring into the possibility of preserving fertility following chemotherapy. The challenge remains in using a regimen that is devoid of cyclophosphamide, but is as effective as the standard regimens that incorporate cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP) followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with convincing results regarding its effectiveness in the early setting, and could be potentially associated with less ovarian toxicity being devoid of cyclophosphamide.

Conditions
Breast Cancer
Being tested
Doxorubicin, paclitaxel
Keywords
Primary breast cancer, Young women, Ovarian function, Sexual function, Eligible for adjuvant or neoadjuvant chemotherapy, Negative hormone-receptor status
Medical subject headings
Breast Neoplasms

What participants receive

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

  • DoxorubicinDrug

    All patients will receive four cycles of doxorubicin (A) (50 mg/m2)

  • paclitaxelDrug

    All patients will receive four cycles paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.

Study groups in NCT02053597
Study groupRoleWhat they receive
doxorubicin and paclitaxelExperimentalAll patients will receive four cycles of doxorubicin (A) (50 mg/m2) and paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.
Receives: Drug: Doxorubicin; Drug: paclitaxel

What is being measured

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

  1. Change from baseline in ovarian function

    Ovarian function will be evaluated using serum FSH, estradiol and AMH. Ovarian failure is defined as serum FSH >40 IU/L. Ovarian insufficiency is defined as serum FSH level from 20 - 40 IU/L. Ovarian reserve will be evaluated by serum AMH. Adequate ovarian reserve is defined as serum AMH >1 ng/ml. Menstrual function will be evaluated by collecting information of the 1st day of last menstrual cycle, and cycle length (days between two menstruating periods).

    Ovarian function will be evaluated using serum FSH, estradiol and AMH. Ovarian failure is defined as serum FSH >40 IU/L. Ovarian insufficiency is defined as serum FSH level from 20 - 40 IU/L. Ovarian reserve will be evaluated by serum AMH. Adequate ovarian reserve is defined as serum AMH >1 ng/ml.

    Measured: At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy

  2. Change from baseline in menstrual function

    Menstrual function will be evaluated by collecting information of the 1st day of last menstrual cycle, and cycle length (days between two menstruating periods). In patients menstruating regularly after 12 months of chemotherapy cessation, information on menstrual cycle will be collected at 6-monthly intervals until developing menopause, disease recurrence, becoming pregnant, whichever occurs earlier, for a maximum period of 5 years after end of chemotherapy.

    Measured: At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy

Secondary outcomes (7)

  1. Ovarian reserve

    A serum AMH determination will be performed at 12 months after the end of chemotherapy. An adequate ovarian reserve is defined as serum AMH >1 ng/ml at that timepoint.

    Measured: At 12 months following the end of chemotherapy.

  2. Occurence of Adverse Events

    This study will use the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, for adverse event reporting.

    Measured: From the signature of informed consent until until the end of study treatment/treatment discontinuation visit 30 days after the last dose of study medication

  3. Impact of treatment on the behavior of menstruation after menses resumption

    In patients menstruating regularly after 12 months of chemotherapy cessation, information on menstrual cycles will be collected at 18, 24 and up to 60 months after end of chemotherapy, until developing menopause, disease recurrence or becoming pregnant, whichever occurs earlier. This information will include the date of last menstrual period, menstruation duration and if 2 or more consecutive menstrual cycles were missed, allowing to assess irregularity and possible cessation of menses.

    Measured: At 18, 24 and 60 months after end of chemotherapy.

  4. Evaluate the impact of a cyclophosphamide-free regimen on sexual function

    Patient will complete two validated health-related quality of life questionnaires, one on menopausal symptoms (FACT-ES version 4) and the other on sexual functioning (FSAQ).

    Measured: At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy.

  5. Evaluate the impact of the regimen on peripheral neurotoxicity

    Patient will complete one validated health-related quality of life questionnaire on peripheral neurotoxicity (FACT-Taxane version 4).

    Measured: At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy.

  6. Pregnancy rate after cessation of chemotherapy

    Number of pregnancies among participants.

    Measured: From end of chemotherapy up until 60 months after.

  7. Event-free survival

    Event-free survival will be calculated from the date of registration to the study to developing local, loco-regional or distant metastasis, secondary malignancies or death. All patients will be considered for the primary efficacy analysis (ITT analysis).

    Measured: From the date of registration up until 60 months after the end of chemotherapy.

Timeline

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

  1. First posted3 Feb 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Why it stopped: due to evolving scientific knowledge in the field that would make the questions being addressed in the trial less relevant

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02053597
Sponsor's protocol ID
CE2142
Other IDs
2013-000173-77
Acronym
TRIUMPH
Status last verified
Sep 2015
First submitted
27 Jan 2014
Last updated
17 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin and paclitaxel in people with Breast Cancer, run by Jules Bordet Institute at 4 sites in Belgium.

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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. 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 was withdrawn before enrolling participants, so there are no results.

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?

Change from baseline in ovarian function (time frame: At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy). 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 NCT02053597.

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 17 Sep 2015.

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