MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Swiss GO Trial Group

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

28 Feb 2023 → ongoing

Decision date (initial)

2024-09-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Roche · Cancer League Fuerstentum Liechtenstein · Reliable Cancer Therapies · Helsana · Cancer League Switzerland · AGO Studiengruppe e.V.

External identifiers

EU CT number

2024-511219-78-00

EudraCT number

2019-002264-27

ClinicalTrials.gov

NCT04111978

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the efficacy of letrozole maintenance therapy after standard surgical and chemotherapy treatment as measured by Progression Free Survival (PFS) compared to no maintenance therapy (placebo)

Conditions and MedDRA coding

epithelial ovarian cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Patients must be ≥ 18 years of age
2. Willing and able to attend the visits and to understand all study-related procedures.
3. Primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low or high grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer
4. (Interval-) debulking performed
5. ECOG-Performance Status 0-2
6. Signed informed consents (ICF-1; ICF-2)
7. Paraffin-embedded tissue or paraffin-embedded cell block (from ascites) available
8. Positivity (≥ 1%) for ER expression (only determined by Histopathology Core Facility of MATAO trial)
9. At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)
10. Negative serum pregnancy test in women of childbearing potential who will get/have gotten a surgical resection or radiation sterilization, prior to the intervention in the therapeutical maintenance setting.

Exclusion criteria 8

1. Progressive disease at the end of adjuvant treatment
2. Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)
3. Pregnant or lactating women
4. Any other malignancy within the last 5 years which has impact on the prognosis of the patient
5. < 4 cycles of chemotherapy in total
6. Contraindications to endocrine therapy
7. Inability or unwillingness to swallow tablets
8. Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose mal-absorption

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome is Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.

Secondary endpoints 4

1. Overall Survival (OS), defined for each patient as the time from randomization until the date of death from any cause.
2. Quality-Adjusted Progression Free Survival (QAPFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression under consideration of the quality of life during this period.
3. Time until First Subsequent Therapy (TFST), defined for each patient as the time from randomization until the date the patient started the next (second line) subsequent anticancer treatment. Patients not receiving a subsequent anticancer treatment at the time of analysis will be censored at the date they were last known to be alive.
4. Quality adjusted Time Without appearance of any Symptoms and Toxicity (Q-TWiST), related to either the progression of the cancer or side effects of the trial medication from randomization until death.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Swiss GO Trial Group

Sponsor organisation

Swiss GO Trial Group

Address

Spitalstrasse 21

City

Basel Town

Postcode

4031

Country

Switzerland

Scientific contact point

Organisation

Swiss GO Trial Group

Contact name

Pamela McLaughlin

Public contact point

Organisation

Swiss GO Trial Group

Contact name

Pamela McLaughlin

Third parties 3

Locations

2 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 42 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications